Overview
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.
Responsibilities
Stay up to date on global medical device regulations, mainly FDA and EU (MDD *****/EEC).
Build regulatory strategies with RA leadership.
Prepare and submit FDA filings (510(k), HDE, IDE, PMA).
Work directly with regulators to secure timely approvals.
Track licenses and renew registrations before expiry.
Support existing products, including change notifications.
Maintain strong knowledge of assigned products.
Act on behalf of RA management when needed.
Lead Design Reviews to meet FDA and EU requirements.
Manage Design History Files and quality records.
Knowledge, Skills and Experience Required for the Role
5+ years' experience in Regulatory Affairs, Design Assurance, or similar (medical devices).
BS, MS, or PhD in Engineering or related technical field.
Hands-on experience with risk management (EN ISO *****).
Strong knowledge of FDA QSR (21 CFR 820), EU MDD, and relevant standards.
Prior experience with US FDA submissions is a plus.
Contacts
For a confidential discussion and more information on the role contact
Courtney Russell
.
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