To vacancy overview

Regulatory Affairs Manager

Brand
Schiphol
Location
Schiphol
Hours per week
40 hours

An amazing international opportunity to lead global regulatory affairs for the largest optical retailer in the work.

We are GrandVision, well-known by our retail banners such as Pearle, Vision Express, Charlie Temple, Apollo, Solaris, and many more!

Our global store network are the go-to locations for all the top brands in the eyewear industry, including Ray-Ban, Oakley, Esprit, Careera, but also popular for our comprehensive selection of exclusive and indie brands.

As Global Regulatory Affairs Manager, you will join an internationally diverse and very supporting Quality Assurance and Regulatory affairs team, working closely with our operating countries (Opcos) across the world and various departments in our HQ providing guidance and interpretation of MDR and ISO 13485 requirements for the design and development of new products, where the world of retail meets medical devices.

One thing is for sure, you won’t be bored in this role which will be dynamic, with visibility of everything that is happening across the company.

We look to recruit the best candidates in the market and welcome applications from across the world.

If you are looking for a role where you will pay an essential part of providing safe products, supporting the eyesight of millions of customers worldwide, read on!

Responsibilities

  • Business level English, both written and spoken
  • Provide guidance and interpretation of MDR and ISO 13485 requirements for the design and development of new products.
  • Develop and ensure regulatory compliance for preparation and submission of new products.
  • Create and maintain Technical Files / Medical Device File and EU Declaration of Conformity.
  • Be up to date with all relevant developments in the regulatory environment and translate these developments into relevant actions for our business.
  • Assess the impact of legislation changes on the business and ensure organization readiness to address them proactively
  • Ensure regulatory requirements are incorporated in test procedures.
  • Ensure all supplier Regulatory documentation is compliant and up to date.
  • Support GVHQ on company registrations of legal entities.
  • Work closely with the QARA teams in local entities.
  • Review and approve labelling for products which GrandVision is Legal Manufacturer.
  • Manage and drive all queries from Competent Authorities, Notified Bodies/Certification Institutes, Customers including local OpCo’s and RFH, Global Suppliers and all economic operators.
  • Maintain Dutch Competent Authority product notification.
  • Participate in cross-functional project teams to represent Global Regulatory Affairs.
  • Collaborate with PMS Manager to file the reportable events to related Competent Authority.
  • Support PMS Manager to manage product’s recall and preparing the field safety corrective action.
  • Handle and investigate regulatory compliance complaints.
  • Maintain familiarity with company range of products as Legal Manufacturer and Distributor.
  • Represent Regulatory Affairs in internal and external audits and support Global QARA team during audits.
  • Create and maintain company regulatory policies.
  • Provide regulatory guidance to departments or development project teams.
  • Ensure dashboard management and KPI achievement.
  • Acting as member of Crisis Management Team in case GrandVision is obliged to perform a product recall.

Key skills, knowledge and experience

  • Bachelor's degree in a technical field such as medical, biological, physical, engineering or material science disciplines.
  • 5-10 years in Medical Devices environment
  • Demonstrated knowledge of creating technical files
  • Demontstrated knowledge on product & entity registration processes inside EU
  • ISO 13485 Knowledge & Skills
  • Experience of working in Regulatory Affairs in a Legal Manufacturer
  • Eyewear industry knowledge, desirable
  • Excellent working knowledge of medical device regulations EU MDR, (21CFR), FDA Law, other global laws and regulations.
  • Be able to interpret regulations.
  • Computer proficiency in Microsoft Office
  • Business level English, both written and spoken

Benefits

In addition to a retail market competitive salary, we offer a scope of additional benefits such as 8% pension contribution, a free pair of glasses, lenses or sunglasses a year (as well as family discount events!), subsidised lunches, commuting expenses reimbursed, discount on various insurances and 25 days holiday a year. We also offer the option to continue working from home 2 days a week in the post covid era.

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.

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.

More about GrandVision

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 across Europe, the Americas, the Middle East and Asia. GrandVision serves its customers in over 7,200 stores and with more than 39,000 employees which are proving every day that in EYE CARE, WE CARE MORE.

After decades of collaboration and two years of efforts and relentless work to make it a reality, EssilorLuxottica and GrandVision officially became part of the same organization as of 1 July, 2021.

Going forward, as part of the EssilorLuxottica family, GrandVision will be able to truly unlock our full potential, and that of the optical industry as a whole, by exploring new paths around product development, digitalization, distribution and innovation.

At the very core have always been our people, who day after day are elevating the importance of vision as a basic human right and to bringing the best eyewear possible to the market. As part of the Group's deeply-rooted culture and values, we are committed to taking care of our employees around the globe and helping them thrive and grow.

Some key figures:

  • 7,260 stores in more than 40 countries
  • 434,000 daily store visits
  • 15.1 million Eyeglass & sunglass sold
  • Over 39,000 employees worldwide
  • Revenue EUR 3.5 billion FY
  • EBITA EUR 266 million

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.

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

Find our Annual Report here: http://annualreport.grandvision.com

NB. If you have not heard back from us after 27 days, please consider your application not to be successful. Due to the number of applications we receive, we are unable to provide individual feedback should you not be selected for an interview.

Recruitment agencies: As we have a dedicated in-house recruitment team, all our positions are strictly no agencies. Please refrain from contacting our staff with prospective candidates as they will not be taken into consideration.

Application process

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

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