Jobbet "Technical Writer, Regulatory Documentation " er udløbet.
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Making life sound better
GN Hearing provides advanced hearing care solutions to people across the world. Joining Global R&D with colleagues across Denmark, China and the US, you will be right in the middle of where it all happens when we develop new solutions and make sure that we follow regulatory requirements.

Be our new regulatory specialist
Stepping into our HQ in Ballerup, you will support Process and Programme Management with regulatory and technical documentation and guidance in the new product development process. Doing so, you will primarily review and produce technical documentation yourself, and secondarily identify, develop, and roll out improvements for our technical/regulatory documentation handling.

Your tasks will be to:

  • Write high-quality technical/regulatory documentation for medical device development projects
  • Review existing documentation and help the project team identify documentation for reuse or rewriting as well as documentation that needs to be developed from scratch
  • Write regulatory rationales justifying the reuse of existing documentation
  • Coach technical specialists and program managers in regulatory matters and technical documentation production
  • Develop templates and processes that enable program managers and technical specialists to evaluate and carry out documentation tasks  

“Your main goal will be to accomplish efficient regulatory documentation while ensuring compliance,” says VP, R&D Office, Lars Sjöbeck.

Technical writer with regulatory experience from the industry
You have a combination of technical system engineering skills as well as regulatory knowledge about the medical device industry. You are ready to put yourself in the driver’s seat as the area specialist, both producing technical documentation and maturing an R&D organization within your field of expertise.

Moreover, you:

  • Bring regulatory knowledge about MDR and Class I/II medical devices
  • Have hands-on experience writing technical/regulatory documentation
  • Have a general understanding of product development principles
  • Are fluent in English in both speech and writing

Would you like to know more?
To apply, use the ‘Ansøg’ link no later than 29. October 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 VP, R&D Office, Lars Sjöbeck on +45 5336 4350.


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