面議(經常性薪資達4萬元或以上) 台北市信義區 1年工作經驗 2天前更新
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.
Job Responsibilities and Essential Duties
• 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 Getinge 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.
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