Senior Manager Regulatory Affairs | Salary Range: $128,000 - $145,000 + 15% bonus | Hybrid (3 days a week) | Full benefits, Medical, Dental, Vision, 401k – 4% match, Flex PTO

**Position Summary:**
The Senior manager, Regulatory Affairs is responsible for developing and executing regulatory strategies for assigned product portfolios and projects across North America (US and Canada). This role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams.

The Senior Manager provides strategic regulatory guidance to support product development, commercialization, and lifecycle management while ensuring compliance with FDA and Health Canada requirements. This role collaborates closely with global regulatory counterparts within the Company’s Group and may supervise regulatory staff and/or lead complex regula...