Regulatory Affairs & Quality Specialist

Our client is a leading provider of infection prevention products and services in the healthcare market, dedicated to delivering high-quality, innovative solutions that improve outcomes and help save lives. 

For their office near Augsburg, they are searching for Regulatory Affairs Specialist to be responsible for the MDR documentation and approvals process for endoscopy devices. 

Your Responsibilities:

  • Strategic preparation and processing of global regulatory approvals for market-leading medical products
  • Device launches in EU/USA under the MDR and FDA
  • Management of the technical file documentation for international approvals in the EU and US
  • Collaborate on risk management for medical devices under ISO 14971
  • Supporting on the MDR transition, and regular contact with notified bodies 
  • A close partnership with other departments for a quick and efficient product launch in multiple markets


Experience Required:

  • Degree educated in scientific studies or engineering
  • 2-4 years of experience in regulatory affairs at a medical device company, specialising in active medical devices 
  • Working knowledge of the MDD/MDR
  • Fluent in German, with very good spoken and written English
  • Experience working with ISO 13485 and EN60601


Please apply with your CV or contact the job poster Rebecca Stevens for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.