Regulatory Affairs Manager

The Regulatory Affairs Manager oversees the day-to-day functions of the regulatory affairs team, developing strategies for medical device approvals and managing submissions to the FDA, Health Canada, and EU notified bodies. This role provides guidance to cross-functional teams on global regulatory requirements, mentors direct reports, and ensures compliance with company policies and international standards. The position involves close collaboration with business partners to maintain global registrations and champion initiatives that improve business systems and compliance.