Regulatory Affairs and Quality Manager
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
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