Medical Device Regulatory Affairs Professional

1 week ago


Middelfart Kommune, Denmark Demant Polska Full time

We are looking for a Medical Device Regulatory Affairs Professional to join our team in Middelfart. As a key member of the Global Quality Department, you will be responsible for ensuring compliance with regulations and industry standards, providing regulatory support to internal stakeholders, and guiding our brands on regulatory requirements.

Your Key Tasks Will Include:
  • Providing regulatory assistance to customer service and other stakeholders
  • Supporting product registration in Eudamed, FDA database, and GUDID
  • Preparing technical documentation (STED file) for all products
  • Creating, reviewing, and maintaining regulatory documentation and labelling

The ideal candidate will have experience in a similar position in an international company, knowledge of ISO 13485 and MDR 2017/745, and strong communication skills.



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