Regulatory Affairs Manager

Responsibilities

• Lead regulatory strategy and submissions for Class II and III medical devices in the U.S.
• Prepare and manage regulatory submissions including 510(k), PMA Supplements, annual reports
• Serve as the US regulatory lead on cross-functional project teams, ensuring alignment with clinical, quality, and R&D functions
• Interpret and apply regulatory requirements to product development, labeling, and review of advertising and promotional materials
• Monitor changes in regulatory requirements and communicate impact to internal stakeholders
• Support audits and inspections by regulatory authorities
• Lead post-market regulatory assessments and submissions, including periodic reports, vigilance reporting, and regulatory renewals
• Manage complaint handling activities, ensuring timely investigation, documentation, and regulatory reporting in compliance with applicable standards

Requirements

• Bachelor's degree in engineering, life sciences, pharmacy, or related field
• Advanced degree preferred
• Minimum 10 years of experience in regulatory affairs within the medical device industry
• Proven track record of successful submissions to FDA
• In-depth knowledge of FDA 21 CFR 820, ISO 13485, and other applicable standards
• Strong communication, leadership, and project management skills
• Experience with eQMS systems and electronic document control preferred