We have a Senior Regulatory Specialist position working for an innovative Medical Devices company in Galway. The Senior Regulatory Specialist will report to the Regulatory Affairs Director and will be responsible for supporting regulatory strategies and manage FDA-focused submissions to secure and maintain approvals for medical device sales in key markets.
Overview of your responsibilities (full job description available on request):
1. Stay up to date on global medical device regulations, mainly FDA and EU (MDD 93/42/EEC).
2. Build regulatory strategies with RA leadership.
3. Prepare and submit FDA filings (510(k), HDE, IDE, PMA).
4. Work directly with regulators to secure timely approvals.
5. Track licenses and renew registrations before expiry.
6. Support existing products, including change notifications.
7. Maintain strong knowledge of assigned products.
8. Act on behalf of RA management when needed.
9. Lead Design Reviews to meet FDA and EU requirements.
10. Manage Design History Files and quality records.
Knowledge, Skills and Experience Required for the Role:
11. 5+ years' experience in Regulatory Affairs, Design Assurance, or similar (medical devices).
12. BS, MS, or PhD in Engineering or related technical field.
13. Hands-on experience with risk management (EN ISO 14971).
14. Strong knowledge of FDA QSR (21 CFR 820), EU MDD, and relevant standards.
15. Prior experience with US FDA submissions is a plus.