Regulatory Affairs Specialist II

Role: Regulatory Affairs Specialist II supporting regulatory submissions and authority interactions for medical devices. Responsibilities: prepare and submit documentation such as 510(k)s, EU MDR technical files, change notifications; respond to FDA and Notified Body queries; support post-approval activities; review labeling and engineering changes; maintain knowledge of global regulatory guidelines; collaborate with cross-functional teams and commercial partners. Requirements: Bachelor’s in Life Sciences or related field; 2+ years in regulatory affairs; experience with 510(k)s, EU MDR submissions, supplements, and change notifications; strong organizational, project management, communication, and attention to detail skills. HighValue: medical devices, 510(k), EU MDR, global/regulatory compliance, post-market activities, cross-functional collaboration. WorkSetup: Office-based, with flexible or remote options not specified.