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.