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.
• 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
• 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.