【Job Overview】
Responsible for regulatory affairs related to product registrations in Taiwan, including license and QSD maintenance, MDR transitions, and post-approval changes. Also supports local quality assurance activities in alignment with global standards.
【Responsibilities】
· Prepare, coordinate, and submit regulatory applications to the local health authority to ensure timely approvals.
· Maintain effective communication with regulatory authorities to track submission status and facilitate the approval process.
· Collaborate with global RA teams to ensure timely and accurate preparation of required documents.
· Review product change assessment requests to ensure compliance with local regulations and post-market requirements.
· Provide regular updates to internal stakeholders on product registration progress and regulatory trends affecting products.
· Maintain and organize regulatory records, including submission dossiers, product licenses, and related communications.
· Support post-approval activities, such as country-specific labeling, Field Safety Corrective Actions (FSCA), and reporting.
· Assist the QRC Manager in maintaining local procedures in accordance with the Global Sales Quality Management System (GS QMS).
· Perform other duties as assigned by the QRC Manager.
Anne Yao
Direct : 02-7720-5802
Mail :
[email protected]