Director of Regulatory Affairs - RespirTech (Plymouth, MN)

Lead Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams to develop and execute compliant regulatory strategies and quality management system (QMS) responsibilities. Own end-to-end regulatory execution from product inception through lifecycle management, drive 510(k) submissions and product changes, manage inspection readiness, internal audits, recall efforts, and adverse event reporting, and strengthen cross-functional partnerships to support innovation and efficient market access.