Senior regulatory specialist
GalwayCollins McNicholas
...and EU (MDD 93/42/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 [...]
Category Fashion & Arts