Position Overview: The Senior Director Regulatory Affairs, Product Development will be responsible for setting enterprise-level global regulatory strategy for Artivions new product development portfolio and leading the regulatory approach for complex, high-risk medical device programs from early feasibility through approval, launch and lifecycle expansion. Oversee and ensure timely, high-quality submissions to global regulatory agencies, including US FDA pre-submissions, IDE, PMA, 510(k), PMA supplements, EU MDR technical documentation, CE Marking, deficiency responses and international strategies for registration.