Regulatory Affairs/Quality Affairs Specialist

Job Title: Regulatory Affairs/Quality Affairs Specialist Reports To: Supervisor, Regulator Affairs Last Update: July 2026 About the job This role collaborates cross-functionally across the organization to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities. Primary Responsibilities Author and manage (under leadership’s supervision) the preparation, formatting, and collection of regulatory submissions …