We, at BVI, are always seeking engaged, innovative, and talented professionals who are interested in growing their career within the ophthalmic industry. We seek individuals who are looking to constantly learn, collaborate and advance eye health across the globe.  Valued BVI employees enjoy a complete benefits package plus a competitive salary. Benefits are individually discussed at time of offer of employment.

BVI is an Equal Opportunity/Affirmative Action (link) employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

All potential candidates interested in an International Position are asked to submit a cover letter and C.V. to internationalHR@bvimedical.com for international consideration.

Regional Regulatory Operations Manager

Location: Latin America

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

The incumbent works with the Senior Director, International Regulatory and Operations to design appropriate strategies in support of all BVI product registration activities, regardless of origin, and is responsible for their oversight and execution. This includes tracking and ensuring timely renewals, planning and management of license-holder and distributor relationships, and leading company interactions with Health Authorities and agencies across the region.

The Regional Regulatory Operations Manager r has deep knowledge of the strategic and operational aspects of regional regulatory compliance and registration requirements for BVI Class I, II and III medical devices.

RESPONSIBILITIES

  • Leads the development of regulatory strategy for the region and plans the resourcing and activities necessary to advance the business in the region.
  • Serves as the regional regulatory subject matter expert and contributes to development of global regulatory affairs strategy and plans
  • Ensures regulatory performance is conducted in accordance with procedures, internal guidelines, and industry / regulated standards and requirements.
  • Works with Quality to plan and manage interactions with regulators; assists during notified body/ competent authorities audits, may act as RA Product Subject Matter Expert (SME).
  • Determines appropriate requirements and balance of Licensing and Distributor agreements and relationships in the Region
  • Manages the company’s relationship with Distributors and License Holders in the Region; oversees their performance, budgets, resourcing and ROI to BVI.
  • Other duties as required

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Strategic and operational planning strengths; able to convert high level concepts to actionable plans, confident in the selection and assignment of appropriate tools and resources.
  • Active participation in leadership and executive-level environments; confident to advocate and negotiate from a strong point of view.
  • Highly skilled at building and maintaining effective and productive relationships with key stakeholders; ability to engage with multiple stakeholders while ensuring alignment, commitment, and compliance.
  • People management and oversight capability, both with direct reports and influencing colleagues from other teams.

Positive, self-motivated, detailed, and hands-on, with the ability to work independently as well as collaboratively across the enterprise.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • 5-7 years of industry experience in regulatory affairs functional leadership role, or in a related area such as quality, technical or clinical research.
  • 10+ years of operations experience in a medical device setting.
  • Bachelor’s degree or higher in an appropriate discipline.
  • Proven knowledge of regulatory requirements, and prior experience working with regulatory agencies; Latin America regional knowledge a plus
  • Experience with Class I, II and III medical devices.
  • Demonstrated experience supporting major regulatory submissions (ANVISA, Cofepris)
  • Project management and leadership experience.

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • Regular sitting for extended periods of time
  • May require occasional travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Credit Controller

Location: Abingdon

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

Credit controller to support cash collection for French customers, including sending invoices, statements, contacting customer and reconciliation work on customer accounts.

RESPONSIBILITIES

  • Liaising with customers, account managers and customer services in order to resolve customer queries
  • Keep system notes up to date, to reflect the collection activities
  • Ensuring customer queries are followed through, that the customer is informed of and satisfied with the outcome
  • Sending monthly statements to all relevant customers
  • Phoning/writing/emailing to customers on a regular basis as required to chase for overdue debt and ascertain reasons for non-payment
  • Sending copy invoices/additional information to customers as requested.
  • Reviewing and approving credit note requests received from Customer Services for appropriate customers
  • Reviewing Credit limits for active customers
  • Support for Credit Controller colleagues in their absence (for example vacation) including English/French language
  • Other duties as required

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Speak French Fluently
  • Have at least 1 year of credit control experience
  • Have experience of Excel and Word including basic pivot tables and vlookups
  • Have experience in a large ERP system (for example SAGE 200, IFS, SAP) (advantageous)
  • Have good attention to detail
  • Be a good team player
  • Be able to work to deadlines and have a “can do” attitude
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients 

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • High school diploma or educational equivalent plus at least 1 year of relevant experience; or equivalent combination of education, training and experience
  • At least 1 year of credit control experience
  • Fluent in English and French

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site

Principle Regulatory Affairs Specialist

Location: Rome

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses), EndoOptik® (Endophotocoagulators) and OptiKon (Phaco and Vitrectomy Systems and accessories).

PURPOSE

The Sr. Regulatory Affairs Specialist will be responsible for preparing gap assessments and preparing updates to BVIs product technical documentation that are required to meet the requirements of Medical Device Regulation (EU) 2017_745 and international registrations. The incumbent will interface with, and assess documents from, various departments such as local and global Regulatory Affairs, Medical/Clinical Affairs teams, R&D, Quality Engineering and Manufacturing. Works in a fast-paced Cross-Functional Team to develop and support EUMDR compliance and helping to global ensure business continuity.

RESPONSIBILITIES

  • Review and understand gap assessments on Product Technical Files against MDR requirements. Review all technical documentation, including, but not limited to, design verification & validation protocols & reports, risk management files, usability protocols & reports, manufacturing process information, biocompatibility evaluation of risk reports, labelling content, list of applicable standards, list of general safety and performance requirements, declaration of conformity, and clinical data.
  • Support the collection and provision of data required to submit to EUDAMED.
  • Work with EUMDR Program Director lead to determine implementation plan to complete updates to technical documentation.
  • Work with regulatory affairs and MDR program work stream leads to ensure technical documentation update timelines are aligned.
  • Participate in regulatory impact assessments as it relates to the MDR and relay the information to product specific RA team member and/or design teams.
  • Identify use of appropriate International standards.
  • Work in coordination with MDR program and monitor MDR government agency laws and regulations through websites and publications.
  • Provide global registration documentation as applicable to the business i.e. renewals and new registrations.
  • Bring MDR Regulatory Affairs questions/issues to the attention of MDR Project Management team.
  • Review and coordinate vigilance reporting and communication with Notified Body and/or local authorities.
  • Interact with Notified Body reviewers and auditors during product technical file active reviews.
  • Determine issues which may create regulatory obstacles; investigate and propose solutions.
  • Serve as MDR Regulatory Affairs team member for promotional materials review and product labeling as they relate to MDR registration and commercialization of medical devices.
  • Participate in the regulatory activities, in accordance with MDD 93/42/EEC, MDR 2017/745 and the international requirements of the reference markets, of PMS – PMCF – CER for the product portfolio
  • Support new product development and sustaining engineering teams to assure collection of appropriate data for Product Technical Documentation (regulatory submissions) and compliance related activities e.g. PMS, significant change assessments, regulatory affairs assessments.
  • To participate in the activities of managing the allocation, implementation, updating and archiving of medical device UDI, in coordination with other company operations.
  • Adhere to and ensure the compliance of BVIs Code of Ethics, all Company policies, rules, procedures, and standards.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of certifications/industry regulations (ISO 13485, MDR 745/2017, 93/42/CE, FDA, CFDA, ANVISA)
  • Orientation for detailed work with emphasis on accuracy and completeness
  • Effective written and oral communication skills in both Italian and English
  • Good organizational and planning skills; drives for results
  • Effective analytical/problem solving skills and able to make appropriate decisions based on data
  • Good interpersonal skills that include working well in a team environment and the ability to lead others
  • Proven ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices
  • Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision
  • Working knowledge of international requirements and quality systems
  • Proficient Microsoft Office suite of applications, including Word, Excel, Teams, and PowerPoint
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients
  • Ability to work independently
  • Ability to manage multiple tasks simultaneously and prioritize work

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Educational University Masters Degree in Engineering or related field and 10 years’ Regulatory Affairs experience; or equivalent combination of education, training and experience
  • Regulatory Affairs Certifications (RACs) preferred
  • Medical Device Industry Preferred
  • Experience with medical device certifications and medical device registrations in EU and non-EU markets
  • Experience with US FDA and other outside the EU regulatory experience preferred
  • Experienced in the skillful preparation of product technical documentation.

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.
  • Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.
  • The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Director, Regulatory Affairs

Location: Rome

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses), EndoOptik® (Endophotocoagulators) and OptiKon (Phaco and Vitrectomy Systems and accessories).

PURPOSE

The Director, Regulatory Affairs will lead the strategic direction and operational aspects of regulatory compliance and submissions for medical devices and diagnostics. The incumbent functions as the regulatory subject matter expert for Technical Documentation filings and global registrations.

This position will be responsible for developing strategic regulatory plans, person with regulatory compliance responsibilities, primary point of communication with global regulatory agencies and with BVI Corporate office.

RESPONSIBILITIES

This position will be responsible for developing a strategic regulatory plan to maintain EU MDD 93/42 EEC documentations as well as transition MDR 2017/745 and other international requirements of the reference markets were applicable.

  • Develop strategic direction and priorities for MDR 2017/745, works with R&D, Technical Teams, Marketing and Quality leadership to define clinical development projects including objectives, work plans, milestones and deliverables.
  • Work with internal and external parties to design and execute BVI SOPs, applied ISO standards (as applicable), including, identifying risks.
  • Review and understand gap assessments on Product Technical Files against MDR requirements. Review all technical documentation, including, but not limited to, design verification & validation protocols & reports, risk management files, usability protocols & reports, manufacturing process information, biocompatibility evaluation of risk reports, labelling content, list of applicable standards, list of general safety and performance requirements, declaration of conformity, and clinical data.
  • Provides overall regulatory compliance site management.
  • Actively support the regulatory submission process, acting as a point of contact for local and/or global regulatory bodies.
  • Supports the collection and provision of data required to submit to EUDAMED.
  • Work with EUMDR Program Director lead to determine implementation plan to complete updates to technical documentation.
  • Ensure regulatory compliance of BVI’s devices with the EU and other global regions and other applicable regulatory jurisdictions, identifying and assessing regulatory risks.
  • Determine issues and problem solves regulatory obstacles; investigate and propose solutions.
  • Responsible for promotional materials review and product labeling as they relate to MDR registration and commercialization of medical devices.
  • Leads regulatory activities and team, in accordance with MDD 93/42/EEC, MDR 2017/745 and the international requirements of the reference markets, of PMS – PMCF – CER for the product portfolio
  • Regulatory SME to support new product development and sustaining engineering teams to assure collection of appropriate data for Product Technical Documentation (regulatory submissions) and compliance related activities e.g. PMS, significant change assessments, regulatory affairs assessments.
  • Lead other regulatory workstreams to manage the allocation, implementation and coordination with other company operations.
  • Adhere to and ensure the compliance of BVIs Code of Ethics, all Company policies, rules, procedures, and standards.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of certifications/industry regulations (ISO 13485, MDR 745/2017, 93/42/CE, FDA, CFDA, ANVISA)
  • Leadership skills, strategic planning, and budget establishment
  • Participates in Sr. Level meetings, regulatory authorities and cross divisional peers activities
  • Orientation for detailed work with emphasis on accuracy and completeness
  • Effective written and oral communication skills in both Italian and English
  • Good organizational and planning skills; drives for results
  • Effective analytical/problem solving skills and able to make appropriate decisions based on data
  • Good interpersonal skills that include working well in a team environment and the ability to lead others
  • Proven ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices
  • Ability to handle multiple tasks and to prioritize/schedule work to meet business needs
  • Working knowledge of international requirements and quality systems
  • Intermediate knowledge of the Microsoft Office suite including Word, Excel, Teams, and PowerPoint
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients
  • Ability to work independently
  • Ability to manage multiple tasks simultaneously and prioritize work

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Educational University Masters Degree in Engineering or related field and 10 years’ Regulatory Affairs experience; or equivalent combination of education, training and experience
  • Regulatory Affairs Certifications (RACs) preferred
  • Medical Device Industry Preferred
  • Experience with medical device certifications and medical device registrations in EU and non-EU markets
  • Experience with US FDA and other outside the EU regulatory experience preferred
  • Experienced in the skillful preparation of product technical documentation.
  • Assumes the Person Responsible for Regulatory Compliance (PRRC) responsibilities

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Important notice to Employment businesses/ Agencies 

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. 

Area Product Specialist

Location: Flanders

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

Loyalty and development of the customer portfolio on the Belgian territory (East & West Flanders), management of customer relations and assistance on site (hospitals, clinics)

RESPONSIBILITIES

Sales Promotion

  • Promote PhysIOL-BVI products and distribution products to ophthalmic surgeons
  • Visit ophthalmic surgeons and the (para)medical staff involved in cataract and retinal operations (6 visits/day);
  • maintain ongoing relations with hospital pharmacists, operating room nurses and other decision makers in the hospital environment
  • Organize product information and demonstration sessions (wetlab) with existing (new products) and potential (full range) end users
  • Ensure and coordinate the placement of IOL consignments in clinics and hospitals with pharmacists and Customer Service
  • Negotiate agreements with purchasing managers and/or hospital pharmacists (sterile material)

Account management

  • Develop customer loyalty through regular contact with the end user as well as nursing staff and hospital pharmacies.
  • Apply the procedures specific to each hospital site for the referencing of new products.

On-site assistance

  • Accompany the operators and nursing staff in the handling of the products before and during the operating room
  • Provide training to hospital staff involved in the handling of intraocular implants, surgical instruments and dispensing products
  • On-site assistance in the management of consignments (intraocular implants and dispensing products)
  • Follow up on the proper functioning of an on-site relationship

Marketing

  • During national and international ophthalmology congresses, active presence on the PhysIOL-BVI stands in order to ensure an efficient and friendly welcome for customers & prospects, promotion of the PhysIOL range and image
  • Collecting and analyzing market information and relaying it to the PhysIOL organization
  • Organization of scientific evenings and/or appropriate and targeted promotional events

Reporting

  • Communicate the agenda of his activities to the Sales & Marketing Manager according to the reporting method in force
  • Write and transmit weekly reports of visits and activities using the ad hoc software (CRM)
  • Communicate to the Back Office all useful information for the efficient organization of the management and follow-up of sales

Communication on the Quality System

  • Communicate all customer complaints and cases of non-compliance to the manager(s) in question and to the QA manager, and fill out and submit the non-compliance form where required
  • Inform the manager(s) in question and the QA manager of any irregularity or problem that may affect your ability to do your job properly

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

General skills

Rigour and sense of quality – You are rigorous and disciplined, follow agreed rules and procedures, including WI and PQ, and strictly observe ISO standards.

Team spirit – You create a positive feeling in the group by promoting harmony, communication and collaboration, and you participate in collective results. You are attentive to internal client-supplier relations.

Effective communication – You communicate spontaneously and transfer information in a relevant and effective way within your department and/or with other departments. You notify any problems encountered.

Specific skills

Sense of responsibility – You take your professional role seriously and feel responsible and directly affected by the consequences of your actions; you are diligent.

Results orientation – You are able to pursue, achieve and even exceed your objectives and produce results on time.

Relations – You effectively develop internal and external contacts and maintain relations to create a competitive business advantage.

Planning and organisation – You are able to organise your activities effectively, taking into account priorities and deadlines, to ensure the established objectives are met.

Persuasiveness – You present relevant information in a convincing manner by using specific, well-constructed arguments. You are able to respond to the customer’s criticisms.

Business sense (overall approach) – You are able to detect the customer’s needs and expectations, whether these have been made explicit or not, and respond appropriately, with consideration for mutual interests.

Sense of service (long-term approach) – You create long-term relationships with customers founded on customer service and satisfaction. You regularly evaluate the quality of the collaboration.

Technical product expertise – You show competence, effectiveness and expertise in the technical product aspects of the function.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Training and education required (minimum): ESTC

(CESS: Certif. of Higher Sec. Education –  ESTC: Short-cycle Higher Education (3 years) –  ESTL: Long-cycle Higher Education (4 years) – Univ-Master (formerly bachelor’s degree)  –  Univ-Doc: doctorate)

Experience: 3 to 5 years, preferably in the medical devices or hospital (pharmaceutical) sectors

Technical knowledge and expertise:  TERR R-W-S: bilingual French – Dutch + EN COMM R

EN: English – NLS: Dutch – Other: other language

TECH: technical – COMM: commercial – SCI: scientific – TERR: language of commercial territory

R: reading – W: writing – S: speaking

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Mechanical Engineer

Location: Rome

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

To be included in the R&D / Technical Team as Project Leader of Medical Devices / Accessories.

RESPONSIBILITIES

To be a proactive member of R&D Team focused on new product development and Improvement projects, reporting directly to Technical Director.
Develop and manage capital projects aimed at improving site productivity.
To lead and/or participate in project teams responsible for all activities dealing with process validation of production equipment, from initial ideas to implementation of processes including costing and budget controls. To seek/source new technologies, suppliers and/or processes to support the continuous improvement strategy of the business.

• To discuss and draft projects specifications with the Team Manager and with the doctors / surgeons selected as opinion leaders.
• To create projects planning and budgeting.
• To develop and run projects in accordance with the approved project planning and budgeting.
• To develop and run projects in accordance with the approved technical specifications, the general technical standards and the specific medical device standards applicable.
• To generate the necessary documentation and deliverables for the products certifications (CE, FDA etc.) and registrations.
• Identify and develop capital projects and take through to completion. This will include development of solutions, evaluations with potential vendors, construction & presentation of Capital Justifications.
• Fully documented trials / validations in accordance with internal business procedures.
• Creation of formal project plans to determine improvement activities and quantify the savings gained through full data and current method analysis.
• Follow the development of prototypes and the testing phase, manage the industrialization of the product until it goes into production.
• The Mechanical Engineer will work with all employees at the plant level, their Direct Manager & local management, identifying Best Practice and staying abreast of all implemented solutions.
• In conjunction with Purchasing, oversee and monitor all order placement for capital projects.
• Actively use Lean Tools on C.I. projects to improve Plant Productivity & Reduce waste.
Additional Tasks
• Writing of validation protocols, validation reports and execution of validations
• Compile specifications, protocols, reports and standard operating procedures
• Equipment installation, commissioning and validation
• Organize investigatory testing as required
• Generate engineering change orders (ECO’s) and progress through to implementation.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Deep knowledge of the properties of the materials in general & specifically of the ones used in the Medical Device field
• Ability to carry out project related activities with little or no direct supervision.
• Medical or experience in a highly regulated environment
• Capital budget experience
• Sound knowledge of Cleanroom & Medical related manufacturing processes.
• Good understanding of CI (Continuous Improvement) principles to include Lean.
• Up to date with the latest Facility based regulations.
• Standards:
• ISO 9001
• ISO 13485
• MDR (plus)
• Good influencing and communication skills
• To be able to work dynamically treating tasks with a sense of urgency
• Proactivity
• Result-oriented

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• University Masters Degree – Mechanical Engineering or other Technical
• English – Fluent
• At least 6 years work experience in Design & Development (Micromechanics and precision mechanics sector) – preferably in the Medical Industry

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Important notice to Employment businesses/ Agencies
BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Principal Regulatory Affairs Specialist

Location: Bidford

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

The Principal Regulatory Affairs Specialist (Principle Specialist) will be responsible for the postmarket activities of and life-cycle management of all BVI ophthalmic devices and the regulations applicable to  US FDA and EU Medical Devices. The Principle Specialist will be a core, cross-functional team member for product submissions and postmarket activities. The Principle Specialist will be responsible for developing EU MDR 2017/745 compliant technical documentation and submissions, maintaining MDD 93/42/EEC technical documentation, performing postmarket surveillance (PMS) plans and applicable reports. This role will be responsible for making decisions related to country specific vigilance, and report and communicate with applicable country authorities.

The Principle Specialist will need a skill set to assess and communicate regulatory impacts of global changes to device clearances,  approvals or other market registrations. This role will require an individual with knowledge of all classifications of devices in US and EU to ensures regulatory compliance and to develop professional and thorough regulatory assessments while ensuring timely and high-quality execution of assigned regulatory deliverables.  This role requires you to prepare responses to FDA  and other authority letters or submissions. This role will support audits. This role will be expected to review and approve product and process changes and labeling and marketing materials according to applicable standards or regulations.

The Principle Specialist will fit best if they thrive in a fast-paced environment and is a self-directed initiator. As the Principal Specialist, you will support the Director of Regulatory in developing a partnership with other departments in designing and enhancing regulatory initiatives to facilitate overall regulatory compliance.

RESPONSIBILITIES

  • Works on global Regulatory Affairs Assessments for product changes and documents appropriately in product technical documentation.
  • Works with minimal supervision and instruction from more experienced staff
  • Takes a technical leadership role on one or more projects of significance e.g. global technical submissions
  • Reports observations/problems clearly and concisely, recognizing and highlighting specific deviations
  • Demonstrates developing strategic and tactical technical leadership skills
  • Applies comprehensive strategic and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
  • Demonstrates strong technical and project management skills, and is actively engaged in regulatory strategy, operations and activities spanning the product lifecycle, business/organizational activities
  • Demonstrate skills and knowledge in areas such as: strategy development, risk assessment and benefit/risk management; monitoring and communicating change in the regulatory environment as well as global communication
  • Plans, conducts and supervises assignments, reviewing progress and evaluating results
  • Recommends changes in procedures
  • Operates with substantial latitude for independent action or decision, and reviews progress with management
  • Adhere to and ensure the compliance of BVIs Code of Ethics, all Company policies, rules, procedures, and standards.

Tasks may include:

  • Utilizing technical regulatory skills to propose strategies on complex issues
  • Monitoring emerging issues and identify solutions
  • Monitoring trade association positions for impact on company products
  • Anticipating regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
  • Assisting in the development of global, regional and multi-country regulatory strategy and updates based upon regulatory changes
  • Support submission and approval/clearance requirements
  • Oversight of postmarket surveillance, vigilance reporting and/or MDR files and field actions
  • Monitoring regulatory outcomes of initial product concepts and provide input to senior regulatory management
  • Assisting in Regulatory due diligence and business integration(s)
  • Technical writing, reviews and feedback e.g. Technical Submissions and Clinical Evaluations reviews
  • Interviewing, and mentoring junior regulatory professionals
  • Successfully operates within Program Management principles

Additional tasks may include:

  • Evaluating risk of and regulatory solutions to product and clinical safety issues and recommend solutions
  • Evaluating proposed manufacturing changes for regulatory filing strategies
  • Managing and executing preapproval compliance activities
  • Assessing the acceptability of documentation for submission filing
  • Negotiating and interacting with regulatory authorities during the development and review process to ensure submission approval/clearance
  • Maintaining annual licenses, registrations, listings
  • Ensuring compliance with product post-marketing approval requirements
  • Reviewing and approving labeling, advertising, and marketing & promotional materials to ensure compliance with regulations and products
  • Reviewing publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information
  • Reviewing and approving required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations
  • Providing regulatory input for and appropriate follow-up to inspections and audits
  • Developing, implementing and managing appropriate SOPs and systems to track and manage product-associated events
  • Submitting and reviewing change controls to determine the level of change and consequent submission requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Orientation for detailed work with emphasis on accuracy and completeness.
  • Effective written and oral communication skills.
  • Good organizational and planning skills; drives for results.
  • Effective analytical/problem solving skills.
  • Good interpersonal skills that include working well in a team environment and the ability to lead others.
  • Proven ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
  • Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.
  • Working knowledge of international requirements and quality systems.
  • Intermediate knowledge of the Microsoft Office suite including Word, Excel, Teams, and PowerPoint.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Minimum of a bachelor’s degree in Mechanical, Electrical, Biomedical Engineering or other scientific discipline
  • Minimum of 7 or more years of regulatory experience in the medical device industry with FDA or ISO regulated environment.
  • Minimum of 9 years of regulated industry experience.
  • RAC certification or Advanced Degree (Masters in Regulatory Affairs) a plus.
  • Experienced in the skillful preparation of product technical submissions.
  • Certified ophthalmic assistant, technician or technologist; or surgical technologist a plus

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Sr. Regulatory Affairs Specialist

Location: Bidford

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

The Sr. Regulatory Affairs Specialist will be responsible for postmarket compliance activities.  This role will support the daily running the business process such as processing ECOs, preparing regulatory affairs assessments and preparing updates to BVIs product technical documentation that are required to meet the requirements of Medical Device Regulation (EU) 2017_745. This role may include EU country specific registration requirements and UDI support.  The incumbent will interface with, and assess documents from, various departments such as Medical Affairs, Regulatory Affairs, R&D, Quality Engineering and Manufacturing. Works in a fast-paced Cross-Functional Team to develop and support regulatory activities related postmarket regulatory compliance and helping to ensure business continuity.

RESPONSIBILITIES

  • Works on global Regulatory Affairs Assessments for product changes and documents appropriately in product technical documentation.
  • Review and understand gap assessments on Product Technical Files against MDR requirements. Review all technical documentation, including, but not limited to, design verification & validation protocols & reports, risk management files, usability protocols & reports, manufacturing process information, biocompatibility evaluation of risk reports, list of applicable standards, list of general safety and performance requirements, declaration of conformity, and clinical data.
  • Support the collection and provision of data required to submit to EUDAMED.
  • Work with EUMDR Program Director lead to determine implementation plan to complete updates to technical documentation.
  • Work with regulatory affairs and MDR program work stream leads to ensure technical documentation update timelines are aligned.
  • Participate in regulatory impact assessments as it relates to the MDR and relay the information to product specific RA team member and/or design teams.
  • Identify use of appropriate International standards.
  • Work in coordination with MDR Program Director to Monitor MDR government agency laws and regulations through websites and publications.
  • Provide guidance to junior members of the Regulatory Affairs staff as related to the MDR project.
  • Bring MDR Regulatory Affairs questions/issues to the attention of MDR Project Management team.
  • Interact with Notified Body reviewers and auditors during product technical file active reviews.
  • Determine issues which may create regulatory obstacles; investigate and propose solutions.
  • Serve as MDR Regulatory Affairs team member for promotional materials review and product labeling as they relate to MDR registration and commercialization of medical devices.
  • Support new product development teams to assure collection of appropriate data for MDR regulatory submissions and compliance.
  • Adhere to and ensure the compliance of BVIs Code of Ethics, all Company policies, rules, procedures, and standards.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Orientation for detailed work with emphasis on accuracy and completeness.
  • Effective written and oral communication skills.
  • Good organizational and planning skills; drives for results.
  • Effective analytical/problem solving skills.
  • Good interpersonal skills that include working well in a team environment and the ability to lead others.
  • Proven ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices.
  • Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision.
  • Working knowledge of international requirements and quality systems.
  • Intermediate knowledge of the Microsoft Office suite including Word, Excel, Teams, and PowerPoint.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Minimum of a bachelor’s degree in Mechanical, Electrical, Biomedical Engineering or other scientific discipline
  • Minimum of 5 years of experience in Regulatory Affairs
  • Minimum of 5 years of experience working in an FDA or ISO regulated environment
  • Experienced in the skillful preparation of product technical documentation.

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Regulatory Affairs Manager

Location: China

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

The incumbent has Regulatory responsibility for premarket approvals/notifications for specified BVI products. He will oversee the development and implementation of strategic and operational aspects of regulatory strategy and execution for BVI Class I, II and III medical devices in China. The incumbent functions as the regulatory subject matter expert on the core team, including providing input into the clinical strategy.

RESPONSIBILITIES

New Product Approvals

  • Adherence to BVI credo and industry code of conduct、ethics and good regulatory practices, comply with local legislation and global regulatory policies.
  • Responsible for the life-cycle management for key new product registration projects, make strategic registration plan for each high priority registration project per set registration timeline per project team, execute regulatory submission and monitor related post market surveillance activities.
  • Responsible for product change impact assessment per applicable NMPA regulation and implement change registration accordingly.
  • Responsible for NMPA extension registration within the set timeframe.
  • Establish strong relationship with related authority agencies to better support BVI product registration and achieve regulatory compliance to meet China panel and industry standard/technical requirement.
  • Actively monitor& analysis any update about NMPA regulation and clearly communicate with global HQ to avoid negative impact for BVI regulatory compliance together with other cross function stakeholders.
  • Responsible for product labelling management including RA data、IFU、label template etc.
  • Support tendering and commercial team’s business events related to regulatory materials.
  • Represents Regulatory Affairs in cross-functional teams as needed.

Regulatory Intelligence

  • Perform tasks related to integrating and maintaining the requirements of new NMPA regulations.
  • Contributes to development and utilization of a Regulatory knowledge base that can enable continuous improvements and drive efficiencies through regulatory processes, including registration management.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • English fluent in written, verbal communication and presentation skills. Strong medical and technical writing skills with an ability to share information in a standardized format to convey complex concepts to a variety of stakeholders
  • Strong working knowledge of NMPA、FDA and EU MDR requirements
  • Excellent analytical skills, with keen attention to detail
  • Ability to plan and deliver against project deadlines
  • Ability to balance multiple priorities simultaneously
  • Ability to resolve complex issues with a high degree of initiative
  • Ability to work independently as well as collaborate across the organization
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Positive, self-motivated, detailed, and hands-on

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in engineering, biology, or related field. Advanced degree and/or RAC preferred
  • 5 years regulatory experience in a medical device organization with Class I, II and III medical devices. Ophthalmology experience and CER practice preferred.

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require travel up to 15%

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Director, Quality

Location: Rome, Italy

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

The Quality Director provides leadership, experience, direction and guidance to their respective team. This position will plan, develop and control in conjunction with Quality leadership, the Quality Management System to ensure that all the quality objectives are met, as well as the improvement in quality, in the operation, in the processes, and the development of products, and that the transfer of processes / projects are implemented in an efficient and effective manner. This position will be responsible for providing support and communication with our operations groups and clients to address design, manufacturing and other problems related to product issues.

RESPONSIBILITIES

  • Assures that all local, national and international standards and regulations are effectively implemented at the site
  • Assures the effective implementation of the BVI Quality Management System
  • Addresses customer quality issues and internally improve cost and competencies in process control / validation studies, root cause analysis, failure mode and effect analysis (FMEA), and the use of process excellence tools.
  • Manage training, document controls, internal audit and other required quality processes
  • Maintain and control plant quality procedures
  • Promotes and executes continuous improvement and excellence activities for transactional Quality Processes and manufacturing processes
  • Develops and implements risk management methodologies
  • Produces advanced quality planning documentation where applicable
  • Actively manages all the goals and objectives defined in the quality management system
  • Responsible for the maintenance of technical files
  • Reviews and approves the validation of new / changes in production processes as necessary
  • Designs and validates the processes of the Quality System where applicable.
  • Participates in the design evaluations where applicable
  • Solves quality problems and eliminates restrictions to ensure that project objectives are met
  • Manages local Supplier Quality Management and sterilization, to improve quality through a review of prequalification, supervision and continuous audit, implementation of engineering changes, validation, product qualification and processes and other procedures and instructions.
  • Analyzes QMS and manufacturing processes using valid statistical methods to assess trends and to assist the administration in the identification and resolution of problems and the effort to improve overall quality. Recommend KPI to measure compliance with quality standards and the effectiveness of corrective actions across all functions
  • Ensures effective implementation of the CAPA; develop and implement initiatives to improve proactive processes
  • Generates quality metrics and establish the measurements to monitor quality costs and cost reduction
  • Ensures the effective handling of customer complaints
  • Maintains the GMP requirements, including environmental and personnel controls
  • Ensures that all Health, Safety and Environmental requirements are met
  • Maintains detailed and accurate records of all activities
  • Responsible for the maintenance of metrics to monitor the general performance of the department
  • Manages external audits by Regulatory Bodies and customers
  • Prepares Management Review
  • Assures appropriate organization and resources to execute quality-related processes
  • Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.  Approves actions on human resources matters
  • Other duties as required

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of FDA and EU medical device regulation is required
  • Knowledge of advanced quality planning, and validation is required
  • High level of knowledge in validations, Experience in SPC, Advanced Quality Planning, Product Validation, QSR 21CFR820, 21CFR803, 21CFR806 and ISO 13485, MDD/EUMDR, CMDCAS, JPAL. MDSAP
  • Excellent communication skills, written and verbal in both English and Italian
  • Flexible work practices and approach
  • Ability to influence and negotiate
  • Proficient in the Microsoft Office suite of applications
  • Excellent project management skills
  • High attention to detail, speed, solution and customer service
  • High standardized work, well organized and meticulous
  • Excellent planning and organization skills
  • Highly competent in number management with good verbal reasoning skills
  • Client Management Skills
  • Expresses high leadership skills and emotional intelligence
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in Engineering or related field and 10 years relevant experience; or equivalent combination of education, training and experience
  • 10 years of experience in a medical device manufacturing environment and 5 years of quality management experience

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Process Engineer Electronics

Location: Rome

All potential candidates interested in an International Position are asked to submit a cover letter and C.V. to GSali@bvimedical.com

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

Support the implementation of Continuous Improvement activities and implement plans to optimize processes and operations in our production plant by the means of Lean Manufacturing strategies, tools and methodologies.

Manage manufacturing industrialization of product portfolio (assembly process, production lines and working stations layout).

RESPONSIBILITIES

  • Verify the manufacturing feasibility of the product by analyzing the systems, equipment and process tools;
  • In case of need for new investments in machines and / or technologies, it guarantees a technical evaluation by identifying the most suitable solution and supports the analysis of the investment and the related pay back;
  • Defines the processing cycles and manufacturing bill of materials of the products entrusted to him;
  • Manage the technical documentation to support the production and in particular: technical documentation of the finished product and of the processing phases, production cycle flow chart, FMEA, control plans, operating instructions, product bills of materials;
  • Plans and supervises the progress of product industrialization through specific procedures and methodologies (DFMA – Desing For Manufacturing and Assembly, project management tools);
  • Promotes solutions for the optimization of production processes functional to the improvement of product quality and / or the containment of production costs;
  • Guarantees the validation of new production machines and any process modifications on existing machines.
  • Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; addressing employee relations issues and resolving problems.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Advanced skills in manufacturing processes design & re-design
  • Knowledge of electronics design tools (Orcad, Altium)
  • Strong knowledge of Project Management tools and methods.
  • Basic knowledge of Lean Manufacturing and Six Sigma
  • Basic knowledge of ISO 13485 “Medical devices – Quality management systems – Requirements for regulatory purposes.”
  • Basic knowledge of safety and the environment according to ISO 14001 and ISO 45001
  • Good communication skills, problem solving skills, result orientation and resistance to stress complete the profile.
  • Advanced Excel spreadsheet skills and Office suite
  • The process engineer must have a strong sense of organization and observation. He must have good listening skills in order to understand the needs of the different departments for which he works. Positive interaction with members of organization (R&D, Quality Assurance, Regulatory Assurance, Global stakeholders).

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in Electronic Engineering or related field and 5+ years relevant experience; or equivalent combination of education, training and experience in Industrial Engineering
  • English fluency in writing and speaking
  • Global Compensation provides guidance on appropriate levels of education and experience for each job grade.

PHYSICAL REQUIREMENTS

  • May require occasional travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Process Engineer Mechanical

Location: Rome

All potential candidates interested in an International Position are asked to submit a cover letter and C.V. to GSali@bvimedical.com

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

Support the implementation of Continuous Improvement activities and implement plans to optimize processes and operations in our production plant by the means of Lean Manufacturing strategies, tools and methodologies.

Manage manufacturing industrialization of product portfolio (assembly process, production lines and working stations layout).

RESPONSIBILITIES

  • Verify the manufacturing feasibility of the product by analyzing the systems, equipment and process tools;
  • In case of need for new investments in machines and / or technologies, it guarantees a technical evaluation by identifying the most suitable solution and supports the analysis of the investment and the related pay back;
  • Defines the processing cycles and manufacturing bill of materials of the products entrusted to him;
  • Manage the technical documentation to support the production and in particular: technical documentation of the finished product and of the processing phases, production cycle flow chart, FMEA, control plans, operating instructions, product bills of materials;
  • Plans and supervises the progress of product industrialization through specific procedures and methodologies (DFMA – Desing For Manufacturing and Assembly, project management tools);
  • Promotes solutions for the optimization of production processes functional to the improvement of product quality and / or the containment of production costs;
  • Guarantees the validation of new production machines and any process modifications on existing machines.
  • Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; addressing employee relations issues and resolving problems.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Advanced skills in manufacturing processes design & re-design
  • Knowledge of mechanical design tools: 2D/3D CAD tools (Autocad, SolidEdge)
  • Strong knowledge of Project Management tools and methods.
  • Basic knowledge of Lean Manufacturing and Six Sigma
  • Basic knowledge of ISO 13485 “Medical devices – Quality management systems – Requirements for regulatory purposes.”
  • Basic knowledge of safety and the environment according to ISO 14001 and ISO 45001
  • Good communication skills, problem solving skills, result orientation and resistance to stress complete the profile.
  • Advanced Excel spreadsheet skills and Office suite
  • The process engineer must have a strong sense of organization and observation. He must have good listening skills in order to understand the needs of the different departments for which he works. Positive interaction with members of organization (R&D, Quality Assurance, Regulatory Assurance, Global stakeholders).

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in Mechanical Engineering or related field and 5+ years relevant experience; or equivalent combination of education, training and experience in Industrial Engineering
  • English fluency in writing and speaking
  • Global Compensation provides guidance on appropriate levels of education and experience for each job grade.

PHYSICAL REQUIREMENTS

  • May require occasional travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Responsable des Ventes Consommables Sud-Ouest

Location: France

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

En tant que promoteur des ventes, le collaborateur participe au développement de la croissance de la gamme de produit mis à sa disposition.

Véritable gestionnaire sur son secteur, il assure par sa présence terrain la promotion et la vente des produits de son portefeuille auprès de notre clientèle dans le respect et l’éthique de la compagnie.

RESPONSIBILITIES

  • Rattaché au Directeur des ventes, ses principales responsabilités sont de constituer et développer un portefeuille de clientèle, principalement ciblé sur les hôpitaux et cliniques et centres privés, dans le but d’atteindre les objectifs définis préalablement.
  • Il doit assurer le développement et le suivi de l’activité auprès des différents interlocuteurs, le transfert technique des produits par l’information et la formation de nos utilisateurs.
  • Il est également en charge de l’application, sur son secteur, des différentes stratégies commerciales définies par la société.
  • Plusieurs objectifs, principalement axés sur les ventes, sont définis annuellement en collaboration avec la Direction. (basé sur la croissance par rapport à l’année d’avant et sur des objectifs par familles de produits)
  • Le promoteur des ventes se doit de faire son maximum pour les atteindre, voir les dépasser.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Techniques de ventes
  • Bonne capacité d’analyse
  • Organiser / Planifier son activité
  • Orientation client et résultat
  • Techniques de communication
  • Gestion de l’information
  • Maitrise de l’anglais (medium) et informatique (Pack Office, Document interne, CRM Sales Force)
  • Travail en équipe
  • Autonomie
  • Gestion et remontée de l’information client
  • Gestion administrative
  • CRM
  • Connaissance des groupements d’achat

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Customer Service Associate

Location: Rome

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

Support customers by providing timely, relevant information, resolving questions, responding to complaints and going the extra mile to engage with customers whilst performing duties in an efficient professional and courteous manner. Act as front-line support for customers, to ensure customers are satisfied with products, services, and features. Building sustainable relationships of trust through open and interactive communication both internally & externally. Maintain records of customer interactions, process customer orders, follow communication procedures, guidelines & policies.

RESPONSIBILITIES

  • Answer email, telephone, fax and postal enquiries from existing and potential customers efficiently.
  • Ensure all customer calls/enquiries are handled within agreed timescales.
  • Record information on calls received; maintain detailed and accurate records through ERP & CRM system.
  • Identify opportunities to “up-sell” during customer interaction
  • Process orders, return authorisations and credit note requests timely & accurately
  • Identify, resolve and record customer interactions liaising with Manufacturing sites and other internal departments and locations as required
  • Prioritise workload, organise own time so that deadlines are met and enquires are answered promptly or passed to the appropriate person
  • Other duties, special projects as required

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of MS Office suite
  • Knowledge of the eye and diseases of the eye
  • Knowledge of Customer Service Skills & Practices
  • Knowledge of company policies & processes
  • Advanced Telephone skills
  • Advanced keyboard accuracy
  • Intermediate Excel skills
  • Ability to use positive language
  • Ability to balance multiple priorities
  • Ability to establish and maintain effective working relationships with coworkers, managers and customers
  • Ability to remain calm, especially when under pressure
  • Positive interactions with members of organisation
  • Time management

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in Business or related field; or equivalent combination of education, training and experience
  • Fluent professional English and 1 other European core language… ( or e.g. Fluent professional French & English)
  • Must have excellent PC/system skills and be computer literate with the ability to learn software programs e.g. Microsoft Office and other databases (ERP Systems)
  • Exceptional attention to detail & accuracy
  • Strong communication & interpersonal skills
  • Strong problems solving skills with high energy and adaptability
  • Understand & demonstrate BVI Vision & Core Values
  • Calm & consistent demeanour
  • Language skills an advantage
  • Demonstrable ability to work within an environment of consensus and cultural sensitivity
  • Customer Service experience would be an advantage.
  • Knowledge of the Ophthalmic Industry or Medical Device Industry would be an advantage

PHYSICAL REQUIREMENTS

  • Extensive use of Monitors & keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Customer Service Team Lead

Location: Rome

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

The Customer Service Team Lead is responsible for supervising a team of Customer Service Specialists to deliver exceptional customer service to BVI’s customers. 

The incumbent acts as escalation support, to ensure customers are satisfied with products, services, and features, and supports customers by providing timely, relevant information, resolving questions, responding to complaints whilst going the extra mile to engage with customers whilst performing duties in an efficient professional and courteous manner.

The role builds sustainable relationships of trust through open and interactive communication both internally & externally, and maintains records of customer interactions, process customer orders, follow communication procedures, guidelines & policies.

RESPONSIBILITIES

  • Maintain measure and communicate department philosophy, policy & metrics.
  • Ensure all customer calls/enquiries are handled within agreed timescales.
  • Support & encourage opportunities to “up-sell” during customer interaction.
  • Process orders, return authorisations and credit note requests timely & accurately.
  • Identify, resolve and record customer interactions liaising with Manufacturing sites and other internal departments and locations as required.
  • Support CSA’s in Prioritising workload, time management to ensure deadlines are met and enquires are answered promptly or passed to the appropriate person.
  • Supervises staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.  Approves actions on human resources matters.
  • The role requires one2one training with CS Associates as well as monitoring engagement/completion of training modules provided by Global Education Team.
  • Other duties, special projects as required

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Fluent professional English and 1 other European core language.. ( or e.g. Fluent professional French & English)
  • Must have excellent PC/system skills and be computer literate with the ability to learn business software programs.
  • Strong analytical & interpretive skills with an ability to manage multiple task.,
  • Exercise good judgment and discretion during decision making process in fast paced team environment.
  • Exceptional attention to detail & accuracy
  • Excellent communication & interpersonal skills
  • Excellent problems solving skills with high energy and adaptability.
  • Understand & demonstrate BVI Vision & Core Values
  • Ability to be calm & consistent under pressure.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in business or related field and 5 years relevant experience; or equivalent combination of education, training and experience
  • Knowledge of the Ophthalmic Industry or Medical Device Industry preferred

PHYSICAL REQUIREMENTS

  • Extensive use of Monitors & keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Quality Assurance Specialist

Location: Vierpolders, Nederland

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

As a Quality Assurance Specialist you are responsible for implementing, guaranteeing and monitoring the quality policy within Vitreq (the Netherlands). You are also responsible for setting up, managing, maintaining and continuously improving the quality management system in accordance with the applicable international requirements for manufacturers of medical devices.

RESPONSIBILITIES

  • implementing, guaranteeing and monitoring the quality policy;
  • setting up, managing, maintaining and continuously improving the quality management system;
  • implementing applicable international requirements in the quality management system;
  • advise and support the introduction of new and changed products, working methods and procedures and ensure that they comply with the applicable international regulations;
  • training and coaching colleagues;
  • providing practical ‘on the job’ support to the operational departments;
  • provide input to Management Review;
  • performing and following up internal and supplier audits;
  • maintaining, following up and continuously improving the complaints management system;
  • initiate and monitor progress of corrective and preventive measures (CAPAs);
  • release of produced products;
  • preparing and assessing study/validation protocols and reports;
  • advising and supervising outsourcing projects.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Demonstrable knowledge of cleanrooms;
  • Knowledge of materials for medical applications;
  • Knowledge of and experience with project management methods / project-based work;
  • Knowledge of Lean Manufacturing (including Kaizen, 3C, 7QC tools and PPS) and statistical methods;
  • Excellent knowledge of MS Office and other work-related software;
  • Pragmatic attitude and contribute to the progress of documentation processes;
  • Good communication skills in Dutch and English (written and verbal, listening, clarifying, interpersonal and influencing skills);
  • Keen detention to detail and accuracy;
  • Ability to work independently as well as part of a team;
  • Planning, controlling & organization skills;
  • Ability to manage time and meet deadlines;
  • Organizational and social awareness;
  • Decisiveness;
  • Proactive, project-, customer- and result-oriented.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • HBO/WO education in Engineering, Biology or Chemistry. ;
  • at least 3 years of demonstrable Quality Assurance work experience in Medical Devices;
  • demonstrable knowledge of and experience with cGMP, MDD/MDR, ISO13485 and QSR 21 CFR 820;
  • certified (lead) auditor ISO13485 is an advantage.

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. 

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Global Training Manager – Equipment & Accessories

Location: US or Europe

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

The Global Training & KOL Manager—Surgical Equipment and Accessories is responsible for global commercial (direct, indirect, and customer service) and healthcare practitioner (HCP) training programs for the BVI Equipment and Accessories portfolio for cataract and vitreoretinal procedures.  Additionally, as a key member of the Global Education Team, this person acts as a cross-functional liaison between BVI and HCPs utilizing clinical, surgical, and technical expertise to support BVI strategic decisions, identify and develop product advocates, lead investigator training initiatives, guide product development, and support product launches for new technologies.

RESPONSIBILITIES

  • Collaborates with cross-functional leaders and global training team assess training gaps, ensure consistency and efficiency in learning initiatives, and provide a positive learning experience for associates
  • Develops, tailors and delivers portfolio training programs diverse audiences with varying levels of clinical and technical knowledge, focusing on surgical, clinical and technical information as well as key marketing messages, features and benefits, and consultative selling
  • Fosters internal team effectiveness to ensure quality live, virtual, and in-field training of new and established territory managers and customer service reps
  • Identify surgeons with advocacy potential and develop relationships to harness engagement in product development, clinical research, marketing evaluations and peer-to-peer advocacy programs
  • Acts as liaison between BVI and HCPs

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Knowledge

  • Deep hands-on understanding of cataract and vitreoretinal surgical procedures and planning, clinical and surgical patient flow, ocular diagnostics, OR protocol, Patient Privacy Guidelines, and reimbursement environments
  • Knowledge of adult learning principles applied through multiple delivery methods (live, virtual, video, online, social learning etc.) as well as learning management system technology and administration
  • Clinical trials knowledge would be beneficial

Skills

  • Robust facilitation, coaching and consulting skills across a variety of people and cultures
  • Strong leadership success driving large-scale, organization-wide projects and changes
  • Demonstrated ability to assess and to translate business strategy into leading-edge training programs.

Abilities

  • Attentive listener and communicator with absolute mastery of English language
  • Learning agility to acquire/apply new practices and information in a fast-paced, constantly changing environment
  • Ability to work in a complex global framework, both autonomously and within a team environment
  • Aptitude to integrate divergent information and develop project plans and actions

Behaviors

  • Team player with demonstrated strong interpersonal skills and ability to build effective working relationships throughout all levels of the organization
  • Quickly and consistently establish rapport and collaborate effectively with internal and external stakeholders
  • Works well under pressure while meeting company timelines

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor Degree with medical or life science focus or allied healthcare certification plus minimum 7 years of clinical work experience
  • Strong business background with minimum 7 years work experience in Ocular Surgery Sales, Marketing, and/or Training roles

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone, video, and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • Regular standing for extended periods of time.
  • May require up to 60% international travel

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Manager, Custom Eyes

Location: Liège, Belgium

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

The CustomEyes Support Specialist is a pivotal role in BVI marketing that supports both the needs our CustomEyes customers and the needs of our business. The CustomEyes Support Specialist responds the CustomEyes inquiries/requests of both customers and the sales team and serves as the “voice of the customer” during internal company meetings. This role is also responsible for monitoring the end-to-end production of our CustomEyes packs from pack samples to new pack submission and helps maintain the appropriate inventory levels of our CustomEyes packs. This role serves as the bridge between our customers/sales team and the BVI operations team and requires constant communication between several BVI departments.

RESPONSIBILITIES

  • Respond to the customer inquiries/requests to the CustomEyes inbox in a timely manner. Create a positive customer experience and maintain relationships with current customers.
  • Serve as a product expert of CustomEyes pack components, be able to make product recommendations to both customers and sales reps
  • Manages product exceptions, substitutions and quality issues as appropriate, in tandem with supply chain, quality affairs and operations
  • Serve as the “voice of the customer” during internal meetings and balance the needs of the customer with the needs of the business.
  • Serve as the bridge in communication between internal BVI operations and the customer/sales team
  • Collaborate with BVI operations team and pack production team in Juarez to ensure the timely production and availability of CustomEyes packs
  • Collaborate with BVI operations team and pack production team to create a weekly update of low inventory packs to be sent to the sales and marketing team
  • Manage and monitor the process for new pack submissions and pack changes, collaborate with all relevant departments to ensure timely completion.
  • Advise marketing of potential solutions to streamline processes and improve communication

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Strong understanding of BVI customer service processes, systems and resources
  • Strong understanding of CustomEyes product offering
  • Ability to establish and maintain effective working relationships with customers, sales reps and BVI coworkers
  • Strong analytical, planning and organizational skills
  • Self-starter with ability to work independently under pressure and react quickly to changing priorities
  • Strong interpersonal and communications skills (oral & written) and experience leading without direct supervisory authority
  • Consistent positive interaction with other members of the team and ability to drive collaborative efforts with cross-functional teams

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in marketing, business, analytics or related field and 3+ years relevant experience; or equivalent combination of education, training and experience
  • com Admin or developer or CPQ specialist certificate

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • May require occasional travel, particularly for remote applicants.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Marketing Manager, UK , Ireland & Nordics

Location: UK

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

The Marketing Manager will be responsible for developing and maintaining marketing strategies to meet organisation business objectives.  The incumbent is responsible for effective development and management of a strategic marketing plan, advertising, promotional/trade show activities of the organisation across sales and marketing channels for key BVI core product categories. The Marketing Manager will work closely with Sales Organisation, KOLs, Global Upstream Marketing, and Sales Training to develop downstream marketing campaigns to meet the needs of their customer and achieve the financial goals of the organisation.

RESPONSIBILITIES

  • Develops targeted marketing plan, collateral, and communication plan to targeted audience through various channels
  • Identify new market expansion and opportunities
  • Plans strategic promotional and advertising investments in Media, as well as plan activities at Trade Shows and Education events.
  • Executes and Monitors results of marketing programs within agreed budget
  • Work closely with Indirect and Direct Sale Organisations to communicate and train on sales and marketing message.
  • Build strong relationships with KOLs to grow the BVI Brand
  • Conducts customer research, analyses current market conditions, and reports competitor information
  • Analyse business results and impact

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Relevant clinical and technical knowledge of ophthalmic surgical procedure, device and/or equipment market
  • Excellent verbal and written communication skills
  • Strategic and critical thinking skills, developing creative solutions for the business and customers
  • Advanced in Microsoft Office suite of applications
  • Experience with Salesforce, PowerBI, Adobe Creative Suite beneficial
  • Ability to develop and manage marketing plans, including budgeting and forecasting
  • Ability to manage multiple priorities simultaneously
  • Ability to resolve complex issues with a high degree of initiative
  • Ability to establish and maintain effective working relationships with coworkers, managers, and customers
  • Works with a high sense of urgency to meet and exceed company and customer expectations
  • Acts as a change agent within the organisation, demonstrating flexibility as business demands change

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in Business, Marketing or related field and relevant ophthalmic sales/marketing experience; or equivalent combination of education, training and experience.

PHYSICAL REQUIREMENTS

  • Use a laptop
  • Use a telephone and other mobile devices
  • Full, clean driving license
  • May require 20% travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Sr. Marketing Manager, LatAm and Iberia

Location: US or LATAM

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

The Sr. Marketing Manager will be responsible for the development of downstream marketing strategies and tactics to drive adoption of the current BVI’s product portfolio and execute successful product launches. The incumbent must have a deep understanding of cataract surgery and the BVI product portfolio to create new customers and enhance the customer experience with existing customers. The Sr. Marketing Manager will work closely with Sales Organization, KOLs, Global Upstream Marketing, and Sales Training to develop downstream marketing campaigns to meet the needs of their customer and achieve the financial goals of the organization.

RESPONSIBILITIES

  • Develops targeted marketing plan, collateral, and communication plan to targeted audience through various channels
  • Identify new market expansion and opportunities
  • Plans strategic promotional and advertising investments in Media, as well as plan activities at Trade Shows and Education events.
  • Executes and Monitors results of marketing programs within agreed budget
  • Work closely with Indirect and Direct Sale Organizations to communicate and train on sales and marketing message.
  • Build strong relationships with KOLs to grow the BVI Brand
  • Analyze business results and impact

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Relevant clinical and technical knowledge of ophthalmic surgical procedure, device and/or equipment market
  • Excellent verbal and written communication skills- Native Spanish speaker preferred
  • Strategic and critical thinking skills, developing creative solutions for the business and customers
  • Advanced in Microsoft Office suite of applications
  • Ability to resolve complex issues with a high degree of initiative
  • Ability to establish and maintain effective working relationships with coworkers, managers and customers
  • Works with a high sense of urgency to meet and exceed company and customer expectations to achieve desired results
  • Acts as a change agent within the organization, demonstrating flexibility as business demands change

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in Business or related field and 5 years relevant ophthalmic sales/marketing experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS

  • Use a laptop
  • Use a telephone and other mobile devices
  • May require 30% travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Senior Global Product Manager, IOLs

Location: Europe

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

Global responsibility for product and life cycle management of current portfolio and pipeline new product development for monofocal IOLs and IOL delivery systems.

RESPONSIBILITIES

  • Work with the Global Marketing Director to contribute towards the global marketing strategies for IOL portfolio
  • Develop and define marketing and business plans by obtaining a clear understanding of the market needs and commercial opportunities, define pricing strategies and market opportunities
  • Develop global product marketing materials
  • Provide technical and scientific support for the global IOL portfolio range
  • Review and monitor market needs and continuously alert for any changes using sources of market intelligence
  • Develop KPIs to monitor and measure product performance
  • Manage IOL brand identity across all media, material and sales channels and ensure brand compliance in line with company brand identity
  • Participate in and actively engage in organising specialist marketing programmes for major industry conferences
  • Build effective working relationships with R&D and QARA departments in facilitating new product development
  • Build strong working relationship with global sales team to facilitate strong coherent link between marketing and commercial
  • Project management as part of the product development programmes within the business
  • Involvement in planning and coordination of clinical work for pre and post-market studies for new and existing products
  • Support key opinion leaders programme initiative (through PR and practice management)
  • Work with the Global Marketing Director to ensure budgets are in line with the business strategy

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Product marketing experience
  • Experience in medical devices or pharmaceuticals
  • Strong creative background
  • Experience launching new products and managing product life cycles
  • Good scientific background, able to comprehend and interpret scientific/clinical data
  • Strong business acumen – financial awareness, strategic thinking, business planning and budgeting, ability to develop and execute key tactics
  • Strong interpersonal skills and relationship builder – KOLs, key partnerships, external agencies etc.
  • Analytical and problem resolution skills
  • Good organisational skills
  • Flexible ‘can-do’ attitude needed to thrive in a rapidly growing and changing company
  • Ability to travel internationally

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in Marketing / Science / Optometry / Engineering or related field and 6 years relevant experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • Requires 30% international travel.

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Global Sourcing Manager, Capital Equipment

Location: Rome, Italy

COMPANY OVERVIEW

BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients.  With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe.  Our team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.   Our trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium Intraocular Lenses).

PURPOSE

The Global Sourcing Manager develops and maintains leading edge global sourcing strategy and appropriate supply base with clear spend governance for assigned Capital Equipment related category(ies), including PCBs, monitors, wire harnesses, molds, casings, tubing and other manufacturing-related Capital Equipment. Categories and associated suppliers are typically global in nature. They are also responsible for key strategic supplier management including risk, performance, relationship, value plan delivery and supplier development.

RESPONSIBILITIES

  • Responsible for the development, communication and approval of sourcing strategies.
  • Sourcing strategies should be inclusive of all regional business requirements and seeking input from manufacturing, supply chain, and other stakeholders throughout the business.
  • Accountable for year-on-year financial impacts to assigned category(ies) with respect to price movement
  • Responsible for leading global category through the supplier selection process and for the approval of selected suppliers by stakeholders. The team-based supplier selection process is inclusive of identification of potential suppliers, RFx development and execution, proposal evaluation against business requirements and total cost of ownership (TCO), and supplier selection recommendation.
  • Upon stakeholder approval and completion of successful negotiation and contracting, the associate is responsible for coordinating the communication of the supply base to the end user community.
  • Responsible, with the input from regional Innovation Centers in the Europe and United States for negotiation planning, negotiation and contracting with suppliers, and insuring that agreements reflect BVI’s needs globally.
  • Demonstrate knowledge of MRP system and supplier business portals for purchasing and services. Develop skills and obtain knowledge in project management, negotiations, and contract terms and conditions. Possess technical knowledge within multiple commodities
  • Development and management of Contract Manufacturing/OEM expense budgets
  • Responsible for overall business management of top-spend, tier-1 Medical Device Contract Manufacturing/OEM suppliers
  • Other duties as required

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Minimum ten years of related work experience, including Capital and EMS category strategy and execution (preferably in the Medical Device industry)
  • Strategic Sourcing Processes including Market Analysis, RFx, Source-to-Pay
  • High-level understanding of ISO 13485, ROHS, IEC60601, EU MDR and other Regulatory processes (e.g. 510(K))
  • Business-level fluency in English (other EU languages an asset)
  • Experience in commoditized and specialty electronics is a plus
  • Supplier Management
  • Strong negotiating ability. Must work with supplier and drive cost saving initiatives
  • Ability to influence without direct authority
  • Written and verbal communication skills
  • Drive for results
  • Cross Functional and International working experience
  • Extensive knowledge of products and services, including but not limited to materials and procurement principles
  • Comfort and courage to operate in new areas of the business with limited direction. A willingness to try, fail, and try again

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s degree in a related field
  • 10+ years sourcing (including Capital category strategy and execution), supplier management, and operational experience required
  • Experience in medical device or pharma industry is a must
  • Experience in indirect leadership of suppliers and contract manufacturers

PHYSICAL REQUIREMENTS

  • Extensive use of keyboard requiring repetitive motion of fingers.
  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
  • Regular sitting for extended periods of time.
  • International travel a must to interact with contract manufacturers and multi-site partners. Expected travel is 15-25%

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

Important notice to Employment businesses/ Agencies

BVI does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact BVI’s human resources department to obtain prior written authorization before referring any candidates to BVI. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and BVI. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of BVI. BVI shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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