Regulatory Affairs Specialist
CurrentFacilitate market access for manufacturers by navigating medical device registration processes in Vietnam, Singapore, and Hong Kong, ensuring timely product launches.Provide strategic advice on registration processes to support client’s product launch plans.Manage compilation and submission of dossiers for medical device pre-market registration, license renewals, and amendments.Conduct in-depth studies of different types of medical devices as part of the registration process with regulatory agencies.Offer consultative advice on Vietnam, Singapore medical device regulations, ensuring compliance and fostering positive client relationships.Improve operational efficiency and compliance by maintaining an efficient tracking system for license and certificate validity, reducing administrative burden and ensuring regulatory adherence.Collaborate with cross-functional colleagues to support medical device regulatory-related tasks during product marketing efforts.