· Provideindependent regulatory strategy and guidance to product development teams,supporting strategic planning, pre‑marketing activities, and regulatorysubmissions to enable timely and compliant product launches and changeimplementations.
· 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, andglobal medical device licensing submissions as applicable.
· Liaisewith and coordinate submissions, registrations, variations, and renewals withglobal regulatory authorities to ensure continued market access.
· Monitorand interpret new and evolving regulatory requirements, standards, andguidance; perform regulatory impact and gap analyses and provide timely updatesand recommendations to management and cross‑functional stakeholders.
· Maintainand manage the product registration database, ensuring accurate tracking ofregulatory submissions, approvals, renewals, and commitments.
· Supportregulatory compliance activities throughout the product lifecycle, fromdevelopment through post‑market maintenance.
· Maintaincurrent knowledge of U.S.FDA regulations, policies, and guidance, EU Medical Device Regulation (MDR),and other applicable international regulatory requirements governing theregistration and distribution of medical devices.
· ManageMedical DeviceReporting (MDR) and Vigilance reporting in accordancewith applicable regulatory requirements; collaborate with internal and externalstakeholders to support field safety corrective actions (FSCA), includingproduct recalls when required.
Perform other regulatory or project -relatedtasks assigned by management