Regulatory Affairs Leader: FDA 510(k) & Global Compliance

Medical Device Company in Bothell, WA, is seeking a Manager, Regulatory Affairs to lead the Regulatory Affairs and Quality Assurance team at the Bothell headquarters. You will own FDA 510(k) submissions, guide global registrations, mentor staff, and shape regulatory strategy in collaboration with Engineering, Clinical, Quality, and Commercial teams. The role reports to the Director of Regulatory Affairs and offers hybrid work with occasional travel.