Regulatory Affairs and Quality Manager

​Regulatory Affairs and Quality Manager


Our Client:

World’s leading manufacturer in the field of respiratory therapy and ventilation and over 50 years of trading.


With such long heritage, they continuously strive to create the most innovative and patient friendly medical technology.


In order to achieve that, they now need an experienced, likeminded RAQM Manager to strengthen their team.



  • Developing and maintaining QMS in accordance with MDR and ISO 13485

  • Carrying out internal and external audits

  • Cooperation with notified bodies as well as local authorities

  • Carrying out root cause investigations and leading appropriate meetings for CAPAs

  • Preparation and maintenance of technical documentation

  • Training employees in quality system procedures


Experience required:

  • Technical/Engineering degree or similar

  • 3 years experience in a similar field of medical devices

  • Strong knowledge of ISO 13485, ISO 9001, MDR and FDA

  • Previous experience in developing, implementing and maintaining QMS

  • Fluent in German and English


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

+49 30 16 63 83 76