Regulatory / QA (Medical Device) HMS

East, up to 6k

• Provide independent regulatory strategy and guidance to product development teams, supporting strategic planning, pre‑marketing activities, and regulatory submissions to enable timely and compliant product launches and change implementations.
• Prepare, submit, and maintain premarket regulatory filings, including U.S. FDA 510(k) submissions, EU Technical Files / Design Dossiers for Class I, IIa, and III medical devices, and global medical device licensing submissions as applicable.
• Liaise with and coordinate submissions, registrations, variations, and renewals with global regulatory authorities to ensure continued market access.
• Monitor and interpret new and evolving regulatory requirements, standards, and guidance; perform regulatory impact and gap analyses and provide timely updates and recommendations to management and cross‑functional stakeholders.