Regulatory Affairs Professional

6 days ago


Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

Radiometer Danmark/Danaher is a leading company in diagnostics, partnering with customers across the globe to help them solve their most complex challenges. We're looking for a highly skilled Regulatory Affairs Professional to join our team and contribute to our mission.

The successful candidate will possess an MSc in Engineering, Pharmacy, Biology, Biochemistry or similar, along with profound knowledge of and experience on best practices with Quality Management System(s) within Medical Devices/Diagnostics.

Your key responsibilities will include participating in and driving smaller projects in the RA/QA function, guiding the organization during External Audits, and planning, facilitating, and conducting training of the organization.

  • Key Requirements:
  • MSc in Engineering, Pharmacy, Biology, Biochemistry or similar
  • Profound knowledge of and experience on best practices with Quality Management System(s) within Medical Devices/Diagnostics
  • Min. 5 years of in-depth knowledge and experience with applicable standards and regulatory requirements (ISO 13485, IVDD/IVDR, MDR, and FDA legislation)
  • Excellent communication and stakeholder management skills
  • Master spoken and written English and Danish language skills


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