美商醫療器材-Regulation Affairs RA Specialist(中和辦公室)
ManpowerGroup
- Zhonghe, New Taipei City
- Permanent
- Full-time
- 職務編號: 4550
- 更新日期: 2024-04-11 14:55:45
- 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.
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）需求條件 / Key RequirementsEducation/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