Regulatory Specialist

The Senior Regulatory Affairs Specialist is responsible for managing regulatory submissions and registrations for medical devices across multiple regions, including U.S. and EU markets. They develop and execute regulatory strategies throughout the product lifecycle, support post-market activities, and ensure compliance with EU MDR and U.S. regulations. Key duties include preparing technical files, leading submission processes, providing guidance on labeling and remediation, and supporting audits and inspections. Qualifications include a bachelor’s degree, experience with U.S. (510(k)) and EU (Tech File/STED) submissions, and knowledge of medical device regulations and standards. Preferred candidates have 4-7 years of experience, regulatory certification (RAC), and strong technical writing skills. This role involves independent work, cross-functional collaboration, and occasional travel, with a focus on fostering innovation and teamwork. #J-18808-Ljbffr