The Role
1. Completing regulatory dossiers for global submissions, including 510(k) applications
2. Maintain existing products, managing variations and renewals
3. Ensure all products remain compliant
4. Assist with both internal and external audits from a regulatory perspective
You
5. 3 years+ experience in Regulatory Affairs specifically within medical devices
6. Good knowledge of MDR
7. Knowledge of ISO 13485
8. Ideally experience with 510(k) applications
9. Due to their location, you will need to have a driving licence and access to a vehicle on office days