To vacancy overview

Regulatory Affairs Specialist

Brand
Schiphol
Location
Schiphol
Hours per week
40 hours

Looking for a role with a global reach?

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, Carrera, but also popular for our comprehensive selection of exclusive and indie brands.

Due to continued growth our Quality Assurance and Regulatory Affairs (QARA) team is looking for a Regulatory Affairs Specialist to join internationally diverse and supportive team.

With our vision to grow and strengthen the global HQ QARA team, this opportunity is amazing for someone looking for a role offering a large scope and the challenges this comes with, as part of an ever-expanding organisation. Your role will not only connect with all departments in our Schiphol based headquarters but also with our growing network of operation countries.

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

Responsibilities

Regulatory Database

  • Create and maintain a regulatory database for Global product registrations/notifications; both for products which GrandVision Group is the Legal Manufacturer or acts as Distributor.
  • Maintain a database with local regulatory requirements impacting product or entity registration requirements
  • Ensure all supplier documentation (DoC, CE Certificates, Packaging & Labelling, IFU), are available and valid within the database
  • Work with suppliers to correct, maintain, and make available the documentation for GrandVision Group.

Registration/Notification

  • Perform and maintain local entity and/or product registrations within GrandVision territory, with a focus on EU countries
  • Ensure documentation is processed correctly to support local registration activities (translation, notarization, legalization, wet signature)
  • Maintain Dutch Competent Authoritty product notification
  • Participate in preparation activities for EUDAMED role-out within GrandVision Group

Supplier compliance

  • Check new global suppliers product compliance to applicable regulatory & quality requirements
  • Review & Approve packaging & labelling as required per Article 14 of the MDR (EU) 2017/745
  • Work with suppliers to correct, maintain, and make available the documentation for GrandVision Group.
  • Work with global suppliers on NC from GrandVision Group concerning compliance of the products distributed

Other activities

  • Participate in cross-functional project teams to represent Global Regulatory Affairs
  • Support Global QARA Team when and where required
  • Ensure the Regulatory Affairs SOP, WI, F are kept

Key skills, knowledge, and experience

  • Bachelor's degree in a technical field such as the medical, biological, physical, engineering or material science disciplines.
  • 2-5 years in Medical Devices environment
  • Demonstrated knowledge of Medical Device Regulations,
  • Demonstrated knowledge on product & entity registration processes inside EU
  • Experience in maintaining or building regulatory product databases
  • Experience in packaging & labelling review and approval processes
  • ISO 13485 Knowledge & Skills
  • Knowledge of EU 2017/745, 93/42/EEC, ISO 13485.
  • Experience with LATAM and FDA regulations is beneficial.
  • Be able to interpret regulations.
  • Willingness to travel as required
  • Be fully proficient in Microsoft Office, including SharePoint and Excel

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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