Sr Manager, International Device Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr Manager, International Device Regulatory Affairs based in the United States. This leadership role will shape regulatory strategy for high-risk implantable medical device programs across international markets. You will lead regulatory planning and execution across Japan, China, and Latin America, supporting successful market access and ongoing compliance. The position offers broad exposure to product development, design changes, submissions, and post-market activities. You will serve as a key regulatory representative in interactions with health authorities, certification bodies, and regional partners. Working across Quality, Clinical, Medical Safety, and global regulatory teams, you will translate complex requirements into actionable strategies. You will also contribute to regulatory intelligence, inspection readiness, and the development of regulatory talent. This is an opportunity to influence global device programs while operating in a collaborative, cross-functional environment.