The Opportunity

We are seeking a highly experienced and strategic Senior Director of Medical Affairs to lead medical and scientific initiatives across our platforms for Heart Valve Therapy (TAVI, TMTI, and Cardiac Surgery), Stroke Prevention (LAA and PFO closure), and treatment of Congenital Heart Disease (ASD, VSD and PDA closure). This role is critical in shaping clinical development strategies, guiding regulatory submissions, and supporting cross-functional teams to ensure the safe and effective use of our products. What You'll Work On Serve as a subject matter expert in heart valve, stroke prevention, and congenital heart therapies maintaining current knowledge of standards of care and relevant medical literature to support internal and external inquiries. Collaborate with R&D, manufacturing, and quality teams to integrate product lifecycle insights into clinical trials; align clinical strategies with commercial objectives. Engage with external Key Opinion Leaders (KOLs) to guide treatment protocols and clinical development. Provide medical and scientific leadership in preparing global regulatory submissions and representing the company in regulatory meetings. Lead the design and approval of clinical strategies, trial protocols, investigator brochures, and study reports. Oversee internal medical monitoring processes, including adverse event reporting and clinical event committees, in partnership with Clinical Affairs and Product Performance. Partner with product development and marketing to define clinical requirements and review promotional and training materials for scientific accuracy and compliance. Investigate product complaints with clinical impact and support post-market surveillance. Author and review internal and external literature, white papers, and Medical Affairs Information responses. Ensure compliance with FDA and global regulatory standards, and maintain collaborative communication across teams, customers, and vendors. Strategic Program Involvement You will also play a key role in the implementation and expansion of the Structural Heart valve platforms. Your strategic contributions may include: Participating in the processes for Investigator Sponsored Studies, Educational and Fellowship Grants, Medical Advisory Board, and Product Complaints. Providing input to R&D, QA, Regulatory Affairs, and Clinical Affairs. Participating in proctor meetings, Medical Advisory Boards, and product summits. Engaging with customers on device efficacy, safety, and future product development needs. Training and supporting U.S. clinical field specialists. Proctoring new U.S. sites and providing ongoing case support. Qualifications MD required; post-graduate degrees preferred. 10+ years as an interventional cardiologist or relevant experience. Strong knowledge of cardiovascular anatomy, physiology, pharmacology, and device interactions. Experience in medical device development and clinical trial design. Skilled in medical monitoring, adverse event reporting, and oversight of clinical events committees. Proficient in medical writing and review of promotional, training, and scientific materials. Ability to assess product complaints and contribute to post-market surveillance. Collaborative experience in matrixed, cross-functional environments (R&D, Regulatory, Clinical, Marketing). Excellent communication, leadership, and multitasking skills in fast-paced settings.