Regulatory Affairs Manager

We are looking for a regulatory affairs manager with background in medical devices to join an exciting company to work on products in the development as well as in post-marketing stage.

Your tasks
* Compilation of complete Technical Documentations of class III products compliant to MDR requirements
* Prepare submission dossiers compliant with national regulations as needed
* Coordinate submission timelines with other departments, Notified Bodies/Health Authorities and business partners
* Critical review of reports and plans as part of these submissions
* Writing of submission summaries

Your qualifications
* Solid experience in Regulatory Affairs in medical device industry
* Experience in collaborating with Notified Bodies and/Health Authorities
* Collaborative, independent working style and good communication skills
* Bachelor or Master degree in natural science
* Excellent English and at least basic / conversational German skills

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.