The Role
As the Regulatory Affairs Specialist, you will be responsible for;
1. Creating technical files for a range of medical devices, both new and existing devices
2. Perform gap analysis and revision of existing documentation to ensure compliance with MDR
3. Respond to and internal or external regulatory affairs queries
You
As the Regulatory Affairs Specialist, you will have the following experience:
4. Regulatory Affairs experience within medical devices
5. Good knowledge of MDD and MDR
6. UK / EU experience
7. Good knowledge of ISO 13485