Medical Device Compliance Specialist

5 days ago


Copenhagen, Copenhagen, Denmark Amoria Bond Full time

Job Description

We are seeking an experienced Regulatory Affairs Specialist to support our client, a prominent company in the MedTech sector.

  • Ensure compliance with EU regulations, specifically the Medical Device Regulation (MDR).
  • Prepare and maintain technical documentation in accordance with MDR requirements.
  • Support regulatory submissions and communication with notified bodies.
  • Review and approve labelling, instructions for use (IFU), and marketing materials.
  • Provide regulatory input to cross-functional project teams.
  • Maintain awareness of changes in regulatory requirements and assess their impact on products.


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