GrandVision is a global leader in optical retailing and delivers high quality and affordable eye care to more and more customers around the world. The high quality eye care offered by GrandVision includes a wide range of services provided by its vision expert, prescription glasses including frames and lenses, contact lenses and contact lens care products, and sunglasses both plain and with prescription lenses. These products are offered through leading optical retail banners which operate more than 40 countries across Europe, the Americas, the Middle East and Asia. GrandVision serves its customers in over 7,000 stores and with more than 36,000 employees which are proving every day that in EYE CARE, WE CARE MORE.
Some key figures:
Developing Careers & Potential
Within all GrandVision companies we recruit for a career, not just a job. We are passionate about customer satisfaction and develop our people to look for growth potential within the job and within the company. Our preference is to always promote internally where possible. So, wherever people start, there’s always somewhere else to go. We strive for continuous improvement and our new recruits help us to further raise the future potential of our company.
Our whole business is full of people who have gone on to achieve a successful career through experiencing a variety of different roles in different locations and area of our business. We continually support and develop our people who have the desire, ambition and potential to grow.
Recalls and CAPA Specialist
The vacancy is based in Schiphol, The Netherlands.
The vacancy is part of the Global Quality Assurance and Regulatory Affairs Department.
Department Vision: Continuously enhance business capabilities by using quality management and regulatory compliance as a tool for competitive advantage.
Department Mission: Develop global processes aimed to achieving streamlined and compliant business operations, both internally at GrandVision and in the interaction with suppliers.
Senior Regulatory Affairs Specialist
Note that the reporting line is likely to evolve in the future.
Main purpose of the role
Key responsibilities of the role include:
A. Establishing and continuously improving global CAPAs, recalls and stock recoveries processes.
B. Ensuring CAPAs, recalls and stock recoveries are executed in compliance with international regulations.
C. Driving and measuring progress of CAPAs, recalls and stock recoveries.
D. Documenting CAPAs, recalls and stock recoveries.
E. Validating and closing CAPAs.
F. Documenting risk assessments liaising with the complaints handling unit and the risk management team.
G. Assisting QARA management to communicate with competent authorities worldwide.
H. Flagging to QARA management any QARA issues detected.
I. Ensuring QARA KPIs are achieved.
J. Ensuring NCs detected during internal and external audits are resolved and documented through CAPA process.
K. Support QARA auditing activities both internal and external.
L. Supporting the QARA team when and where required.
The role is based in the GrandVision Head Quarters. However, occasional international travel will be required.
Key performance indicators
Performance will be measured based on QARA KPIs.
Required qualifications/level of education
• The ideal candidate should have experience in a regulated industry (medical device preferred).
• An academic degree in a related discipline (e.g. science, engineering or philosophy).
Core competencies/ Personal attributes
• Ability to work cross-functionally within a global organization.
• Strong but fair and data-driven personality.
• Ability to prioritize workload.
• Willingness to work hands-on with procedures and records.
• Ability to distill information and take agreed decisions when dealing with conflicting stakeholders.
• Strong planning, problem analysis and resolution, and organizational skills.
• Detect deviations from intended workflows and processes, with exceptional attention to details.
• Learn quickly and effectively, approaching new challenges by taking initiative.
• Scope, manage and prioritize multiple small projects simultaneously.
• Effectively present information to others, including senior management of GrandVision and its subsidiaries.
• Communicate clearly with all areas of the business.
• Team-oriented with strong leadership and interpersonal skills.
• Able to effectively adapt to change (environment, requirements, roles, objectives).
• Demonstrated leadership and change management ability.
• Learning agility.
Key skills, knowledge and experience
The ideal candidate shall:
• Be able to interpret regulations.
• Have previous experience in a similar role in a regulated industry (preferably medical device).
• Be willing to take on board new challenges with enthusiasm and professionality.
• Be fully proficient in English, particularly written, and Microsoft Office.
• Knowledge of EU 2017/745, 93/42/EEC, ISO 13485, 21 CFR 820.100, 21 CFR 803 and 21 CFR 806 is desirable.
Future potential/ learning agility/ growth opportunities
The successful candidate will work cross-functionally with a wide variety of international stakeholders, and therefore there is possibility to learn and grow professionally from the interaction with each of those.
NB. If you have not heard back from us after 27 days, please consider your application not to be successful.