The Role
This is an exciting opportunity for someone develop their RA career. You will be responsible for managing a small team whilst remaining hands on. You will be the SME for all regulatory queries, internally and externally.
1. Manage a small team (approx. 4)
2. Remain hands on, creating regulatory technical files for new products as well as maintaining those for existing products
3. SME for all regulatory queries, both for the team internally and external partners / agencies
4. Manage internal stakeholders and provide regular feedback and updates regarding regulatory matters
5. Work on a UK/EU basis with some US work (FDA) as well.
You
To apply for this role as Regulatory Affairs Manager our client is hoping for someone with the following skills and experience;
6. Ample experience in a Regulatory Affairs Manager role
7. Good experience in medical devices
8. Knowledge of MDD/MDR
9. Good knowledge of ISO13485
10. Worked on a global basis, ideally including FDA experience (desired not essential)