To vacancy overview

Global Quality Assurance and Regulatory Affairs Manager

Brand
Schiphol
Location
Schiphol
Hours per week
40 hours

 

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 37,000 employees which are proving every day that in EYE CARE, WE CARE MORE.

 

Some key figures:

  • 7,000+ stores in more than 40 countries
  • 30 retail banners
  • over 800,000 store visitors per day
  • ~17 million prescription glasses sold
  • Revenue 2018: EUR 3,7 billion
  • EBITDA 2018: EUR 576 million
  • Over 37,000 employees

 

Our vision is to provide high quality and affordable eye care to more and more people around the world. By doing so, GrandVision aspires to help them realize their full potential in life.

 

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.

With customers, stores and employees located in over 40 countries, GrandVision shows diversity to be at the core of its success. Grandvision is a global company proud and committed to be an equal opportunity employer.

(based in Amsterdam)

Main purpose of the role

The person appointed for this role will be Group Management Representative (ref. EU 2017/745), Manager with Executive Responsibility (ref. 21 CFR 820), and in charge for Quality & Regulatory (QARA) for all GrandVision, globally: >EUR 3.7bn, >37,000 employees, subsidiaries in >40 countries, all product categories (Class I, II and III; both active and passive; both sterile and not).

Specifically, the person appointed for this role will have global accountability and responsibility for:

  • Regulatory Compliance of HQ and Operating Companies globally.
  • Regulatory Registrations and Clearances.
  • CE-marking.
  • Quality Assurance.
  • Quality Control.
  • Complaints Handling.
  • Recalls.
  • Custom Compliance.
  • Verification and validation.
  • All (49) GrandVision ISO 13485 certification processes.
  • The Global Quality Management System.
  • Achieving all Quality & Regulatory KPIs.

The person appointed for this role will also be heading the full Quality & Regulatory organization, worldwide, including:

  • More than 25 Quality & Regulatory teams located globally, each of them managed by a Local Quality & Regulatory Manager.
  • All the Quality & Regulatory cluster managers.
  • Five teams in the Headquarters (3 teams based in Schiphol, 1 in China and 1 in Germany).

Required qualifications/level of education

  • In-depth knowledge of Regulation EU 2017/745.
  • In-depth knowledge of Title 21 of the Code of Federal Regulations.
  • In-depth knowledge of ISO 13485.
  • Master’s Degree in Engineering or Law.

Core competencies/ Personal attributes

  • Accurate, structured and data-driven personality
  • Ability to take agreed decisions when dealing with conflicting stakeholders.
  • Ability to prioritize workload and work under time pressure
  • Learn quickly and effectively.
  • Communicate clearly with all areas of the business and maintain inter and intra departmental relationships.
  • Able to effectively adapt to change (environment, requirements, roles, objectives).

Key skills, knowledge and experience

  • The ideal candidate shall be a world-class expert in regulations for medical devices and in managing product and business process quality.
  • The ideal candidate shall be used to manage large team in multinational organizations.
  • The ideal candidate shall be used to host FDA inspections and Notified Body audits.

 

More about GrandVision: www.grandvision.com
Follow us on LinkedIn: https://www.linkedin.com/company/grandvision

Application process

1. Apply
2. Questionnaire & Recruiter call
3. 1st Interview
4. Online Assessment & 2nd Interview
5. Offer
6. Hired

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