Senior Regulatory Specialist

• 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. • Maintain and manage the product registration database, ensuring accurate tracking of regulatory submissions, approvals, renewals, and commitments. • Support regulatory compliance activities throughout the product lifecycle, from development through post‑market maintenance. • Maintain current knowledge of U.S. FDA regulations, policies, and guidance, EU Medical Device Regulation (MDR), and other applicable international regulatory requirements governing the registration and distribution of medical devices. • Manage Medical Device Reporting (MDR) and Vigilance reporting in accordance with applicable regulatory requirements; collaborate with internal and external stakeholders to support field safety corrective actions (FSCA), including product recalls when required. • Perform other regulatory or project-related tasks assigned by management.