Senior Regulatory Affairs Representative
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Ballerup
Would you like a central headquarter position, collaborating with colleagues and external stakeholders from across the world to ensure smooth and efficient market access?
“In this position, the whole world is your playground when it comes to exploring regulatory environments and making sure that our high-quality hearing aid solutions reach users across the world. We have huge ambitions for Regulatory Affairs, so this is a great time to join us.”
- Head of Regulatory Affairs Henrik Johanning
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:
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
Would you like to know more?
To apply, use the ‘APPLY’ link no later than 25 May 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 Head of Regulatory Affairs, Henrik Johanning on +45 4575 1585.
“In this position, the whole world is your playground when it comes to exploring regulatory environments and making sure that our high-quality hearing aid solutions reach users across the world. We have huge ambitions for Regulatory Affairs, so this is a great time to join us.”
- Head of Regulatory Affairs Henrik Johanning
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 to conduct technical file reviews and ensure regulatory documentation
- Complete 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 external/internal audits, e.g. at our sites across Europe, Asia and the US, including up to 30 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 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 25 May 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 Head of Regulatory Affairs, Henrik Johanning on +45 4575 1585.
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 6.5.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Apoteker
- Ballerup
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