Senior Regulatory Specialist

. 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