Senior Quality& Regulatory Affairs Manager
A genetic testing company who focused on inherited diseases are looking for an experienced and hands on QARA Manager oversee the regulatory functions of their site in Espoo, Finland. The Senior Quality and Regulatory Affairs Manager will be an integral part of their QARA team.
Responsibilities
- Oversee RA functions
- Maintain compliance with international regulatory requirements
- Interface with regulatory and Notified Bodies
- Work on Pre Market Submissions
- Requires experience working with MDR / IVDR / FDA
- Fluent English
Requirements
- Bachelors degree in Science or related field
- 7+ years of industry experience
- Good working knowledge of MDR/IVDR/FDA
- Experience working with Diagnostics, Regulated bodies or Notified Bodies is an advantage
- Experience in a leadership position/Management position
- Ability to be Hands on and lead from the front.
