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.

Positions:

  • Quality Assurance Engineer
  • Regional Regulatory Operations Manager- Latin America
  • Credit Controller- Abingdon
  • Principle Regulatory Affairs Specialist- Rome
  • Director, Regulatory Affairs- Rome
  • Mechanical Engineer- Rome
  • Area Product Specialist- Flanders
  • Principal Regulatory Affairs Specialist – Bidford
  • Sr. Regulatory Affairs Specialist- Bidford

Quality Assurance Engineer

Location: Bidford

Overview:

Reporting to the Quality Manager to provide a quality assurance function at the BVI Bidford site. This will include:

  • Liaise with production and supplier personnel as appropriate on quality issues
  • Maintain and develop knowledge of quality improvement techniques
  • Undertake quality improvement projects

Key Responsibilities:

  • Responsible for producing quality specifications, purchasing specifications and procedures and for their consistent implementation.
  • Responsible for Validation of new or existing processes (where appropriate) in conjunction with process engineering.
  • Responsible for investigating and resolving quality issues and providing production support.
  • Responsible for liaising with production, quality, supplier and technical personnel to identify and implement quality tools (e.g. Six Sigma, Lean)
  • Responsible for supporting the internal quality audit function.
  • Responsible for preparing summary reports for management review and other formal review meetings.
  • Responsible for coordinating activities relating to CAPAs/NCRs & SCARs.
  • Responsible for maintaining IFS QM module.
  • Responsible for adhering to the requirements defined within the Company’s health & safety, environmental and quality policies and systems.
  • Responsible for addressing QA issues as directed by the Quality Manager.
  • To ensure that you as an associate meet the requirements regarding Quality and GMP standards as detailed in the Company Quality policy.

Requirements:

  • Minimum HNC/HND or equivalent in engineering or related Quality discipline and/or relevant experience gained within BVI or similar manufacturing environment.
  • Minimum of three years’ experience in a Quality Assurance role, preferably gained within the medical devices industry.
  • Regulatory affairs experience a benefit but not essential.
  • Knowledge of medical device regulations (FDA, ISO 13485, MDD and EU MDR).
  • Trained internal auditor to ISO 13485.
  • Good problem analysis ability.
  • Knowledge of Six Sigma techniques an advantage.
  • Must be able to work in cleanroom environment.
  • Good interpersonal and communication skills.
  • Must be computer literate with knowledge of Microsoft Office software an advantage.
  • Must be willing to participate in Developmental training programs.
  • Must be able to maintain confidentiality in support of the Company and its Associates.
  • Adhere to and maintain the Company’s Health and Safety Policy.

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. 

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 the Operations team focused on development of new and current manufacturing processes, improving efficiency, utilisation and reduction/elimination of all waste forms through the use of lean tools and techniques.

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.

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.

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.

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