Senior Manager, Regulatory Affairs

The Senior Manager, Regulatory Affairs provides strategic and operational leadership for global regulatory activities supporting the company’s portfolio of FDA Class II and EU MDR Class IIb medical devices. This position is responsible for developing and executing regulatory strategies to secure and maintain product approvals, registrations, and market access globally, with particular emphasis on international markets. The role serves as a key regulatory partner to product development and cross-functional teams, providing guidance throughout the product lifecycle and ensuring compliance with evolving global regulatory requirements.