Full-Time Senior Regulatory Affairs Manager

The Senior Manager, Regulatory Affairs oversees regulatory strategies and submissions for medical devices across North America, including FDA and Health Canada compliance.They lead the preparation of filings such as 510(k)s, PMAs, and Licenses, serve as a key regulatory partner to cross-functional teams, and manage interactions with regulatory agencies.Additionally, they guide product development, assess regulatory impacts of changes, review documentation, and monitor industry trends.The role involves managing 1-3 regulatory staff, developing global regulatory strategies, and ensuring timely, compliant deliverables.Minimum qualifications include a Bachelor's in a related field, 7-10 years in medical technology, and 5+ years of team leadership.Preferred qualifications include experience with FDA and Health Canada submissions across device types, strong project management, and excellent communication skills.This hybrid position offers a salary range of $128,000-$145,000 plus a 15% bonus, full benefits, and flexible PTO.