Senior Director, Regulatory Affairs - Product Development

Role: Senior Director of Regulatory Affairs leading global strategies for Artivion's high-risk medical device development portfolio, from early feasibility to lifecycle management. Responsibilities: establish and oversee regulatory pathways, manage submissions (FDA IDE, PMA, 510(k); EU MDR; international registrations), lead agency negotiations, advise on clinical evidence strategies, ensure compliance with global standards, and collaborate cross-functionally with R&D, Clinical, Quality, and Commercial teams. Qualifications: Bachelor's in science or engineering, 10+ years in medical device regulatory affairs with leadership experience; proven success with Class II/III devices, global submissions, and agency interactions. HighValue: medical devices (high-risk, Class II/III), regulatory strategy, global registrations, FDA and EU MDR expertise, clinical evidence alignment, cross-functional leadership, senior stakeholder management. WorkSetup: not specified.