Regulatory / QA (Medical Device) HMS

East
up to 6 k

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.

Interested candidates, do submit your resume to : [email protected] OR telegram @jocelynchan

Jocelyn Chan| Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R1331820