Senior Regulatory Affairs Specialist Medical device

Senior Regulatory Affairs Specialist Medical device responsible for leading global market expansion and new product introductions for Class I, Class II (US) and Class IIa (EU) medical devices.

Requirements

• 7+ years of experience in QA/RA roles within the medical device, dental, or healthcare industry with global submissions experience
• Experience with ISO 13485, EU MDR, and FDA 21 CFR Part 820 requirements
• Experience with global submissions and registrations of medical devices
• Experience with additive manufacturing and Class I/II medical devices
• Familiarity with eQMS tools and regulatory databases (e.g., EUDAMED, FDA portals)
• Strong writing, documentation, and analytical skills
• Demonstrated expertise in negotiating and maintaining relationships with authorized representatives, consultancy providers, including contract signing and service agreement management.
• Experience with project management includint managing multiple projects