Regulatory Affairs Specialist

vor 3 Wochen


Düsseldorf, Deutschland EPM Scientific Vollzeit

Regulatory Affairs Specialist (m / f / d)


As a Regulatory Affairs Specialist (m/f/d) you’ll take ownership of all Regulatory topics in a very critical role to the company’s future and help to fulfil relevant national and international regulatory requirements.


Your Responsibilities Will Include, But Are Not Limited To:


  • Creation and update of 510(k) regulatory documentation for devices and instruments (Premarket Notification, Letter to File, etc.)
  • Selection and justification Predicate Device (Performance)
  • Verification of material suitability (Biokomp strategy)
  • Ensuring the correct implementation of labeling
  • Announcement/Listing and contact person for FDA
  • Updating the documentation for product changes (LtF,
  • Argumentation regarding change of intended use, etc.)


Key Requirements:


  • Completed bachelor's degree
  • Over three years of professional experience in Medical Device industry
  • Fluent knowledge of English and German B2
  • Sound knowledge of MS Office applications
  • Very structured way of working


If you are interested in the role, apply online today.



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