Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product

Role: Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Products, leading regulatory strategy and team for medical devices and combination products. Responsibilities: oversee global submissions, develop and implement regulatory strategies across regions (US, EU, UK, Japan, China), ensure lifecycle compliance, lead cross-functional collaboration on evidence generation, risk management, and post-market activities, and represent regulatory affairs in executive governance and regulator interactions. Requirements: MS, PhD, or PharmD in scientific or engineering discipline; 20+ years industry experience, including 10+ in regulatory affairs; proven leadership in device or combination product regulatory submissions (IDE, 510(k), De Novo, PMA, MDR); strong knowledge of FDA (CDRH, CDR, OCP), EU MDR/IVDR, and global standards (ISO 13485, 14971). HighValue: expertise in medical device/combination product development, global regulatory policy, lifecycle management, risk mitigation, and post-market surveillance. WorkSetup: hybrid in Boston, MA; travel required.