Regulatory Affairs Specialist

What you’d do

Support the regulatory team with international and domestic filings, including drafting and compiling 510(k) Premarket Notifications, technical files, and STED documents. Coordinate with regional regulatory staff on product changes and health authority inquiries. Full time. Found on the employer's careers page on Oct 18, 2026. Apply through the link.

You’ll need

• 2+ years in medical device Class II/III environment
• Bachelor's degree, preferably Engineering or Life Sciences
• 510(k) Premarket Notification experience
• Technical file and STED documentation
• Strong documentation and record tracking skills