【工作內容】
Responsibilities:
• Support medical device product registrations, QSD registrations, license renewal
• Respond to regulatory TFDA’s registration requirements
• Maintain and archive regulatory and quality documentation (document master list, SOP…etc) to ensure compliance with the relevant local regulatory and quality (QMS, GDP) regulations and requirements.
•Prepare and review product labeling
•Support all QA activities (QMS, GDP, internal audit, CAPA …etc), including Post Market Surveillance reporting to TFDA.
1. 支援醫療器材產品註冊、QSD註冊、許可證更新
2. 處理TFDA監理註冊事項
3. 維護歸檔品質文件(文件主清單、SOP 等),確保符合當地相關監管和品質法規和要求
4.審查產品標籤作業
5.支援QA 項目(QMS、GDP、內部稽核、CAPA 等)
Education/Experience Requirement :
• Bachelor degree or above in medical technology, life science, or related is required
• 1-2 years RA/QA experience in Medical Device Industry is preferred
• Written and verbal communication skills
Location: New Taipei City, Zhonghe District (office-base)
待遇面議