Staff Regulatory Affairs Specialist

The Staff Regulatory Affairs Specialist prepares and executes regulatory submissions to obtain and maintain market authorization for medical devices in the United States, Europe, and other international markets. The role leads regulatory affairs activities, ensuring compliance with global regulations throughout the product lifecycle while partnering with cross-functional teams to support product development and commercialization. Key responsibilities include managing FDA 510(k) submissions, evaluating technical and clinical data, and developing regulatory strategies to support organizational goals.