Job Description

Job Description When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world. Job Description:As a Regulatory Affairs Specialist within the Genetic Science Division (GSD) and Clinical Next-Generation Sequencing Division (CSD), you will play important role in impacting patient's life and improve global health outcome. Your expertise will contribute in maintaining the regulatory compliance of the organisation and ensuring our product meets the relevant regulatory requirements. Tasks and Functions:Partner with global, regional and local team members to ensure timely product registrations in SEA region.Prepare accurate submission dossier based on CSDT, or other relevant formats.Ensure license are maintained in accordance with commercial needs. Tasks includes re-registration, renewal, amendment, change notification, etc.Report MDR/ Adverse Event/FSCA/Recall to regulatory authorities, if needed.Review labelling and promotional materials for regulatory compliance.Ensure the registration records and database are properly maintained.Support regulatory intelligence related assignment.Adhere to procedures to ensure compliance with ISO 13485, MDSAP, US FDA, IVDR, and ISO 9001 standards.Handle other works assigned by supervisor. Education and qualification