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Senior Regulatory Affairs Representative

GN Store Nord



Senior Regulatory Affairs Representative

Would you like a central headquarter position, collaborating with colleagues and external stakeholders from across the world to ensure smooth and efficient market access?

Making life sound better around the globe
As part of a global leader in intelligent audio solutions, GN Hearing provides people across the world with advanced hearing aids that let you hear more, do more and be more than you ever thought possible.

At our HQ in Ballerup, you will become part of Regulatory Affairs in Corporate Quality. As part of Global R&D, we make sure that new and existing products gain market access across our global, regional and local markets.

Drive and teach efficient regulatory compliance
Your goal is to prepare and implement product regulatory strategies and support an efficient release of products across GN Hearing. Doing so, you will provide valuable support and guidance to colleagues across our markets and make sure that products gain the necessary approvals to ensure timely market access across e.g. the EU, the US and Asia.

More specifically, you will:

  • Participate in R&D product development projects as RA Lead
  • Support submissions to the FDA and notified bodies and manage the process of reaching product approval and certification
  • Provide guidance and training to all functional groups involved in the process of medical device registrations to equip them with the necessary knowledge about relevant external regulatory standards and regulations
  • Participate in/manage team projects, e.g. to assess new standards and regulation and develop new road maps for regulatory compliance
  • Support our Biocompatibility Safety Officer in developing and executing on biocompatibility planning and testing
  • Support external/internal audits, e.g. at our sites across Europe, Asia and the US, including up to 15 travel days a year

Make your mark on a growing regulatory affairs function
In Regulatory Affairs, you will join 10 regulatory affairs professionals and specialists. Furthermore, you will join a function with extremely high ambitions as GN Hearing is in the middle of a strategic transformation that entails an intensified focus on pursuing quality excellence. This means you will have immense impact on how we approach regulatory compliance and overall quality in the future.

Regulatory affairs specialist within medical devices

  • You have experience working with medical device standards, guidelines and regulations – more specifically, ISO 13485, MDSAP and FDA 820 quality-based systems
  • You have experience working with ISO 10993 and biocompatibility for medical devices
  • You have a bachelor’s or master’s degree or similar within a natural science or engineering
  • You have some experience with project management
  • You communicate effortlessly in spoken and written English
  • It is a plus if you know about the FDA pre-submission process 510(k)

Would you like to know more?
To apply, use the ‘APPLY’ link no later than 31 July 2020. Applications are assessed on a continuous basis, which is why we encourage you to send your application as soon as possible.

If you want to know more about the position, you are welcome to contact Director Regulatory & Compliance, Karen Bryde Frisk on +45 27 88 96 23.

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Placering
Lautrupbjerg 7
2750 Ballerup
Logo: GN Store Nord
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