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【Summary】 此職務角色不僅只是從品質系統的規範去要求流程品質以符合客戶要求， 需相信、認同並能專注在協助組織實踐 TQM 的核心理念，並使同仁在系統流程的認知上具有更加良好的品質觀念，從
36K ~ 45K TWD / month
2 years of experience required
No management responsibility
品註冊(TFDA/FDA)、查驗登記、展延、變更等相關工作，確保公司產品能夠合法上市並維持許可狀態。 協助ISO 13485/GDP品質系統的維護、稽核及記錄，確保公司品質體系符合相關標準。 熟悉醫療器材法規，並協
30K ~ 42K TWD / month
1 years of experience required
No management responsibility
Regulatory Affairs 法規人員 協助準備產品上市註冊及程序文件 辦理國內外醫療器材產品註冊(TFDA/FDA)、查驗登記、展延、變更、上市後監督 協助ISO 13485/GDP 品質系統維護、稽核及記錄。 建立並維護醫療器材相關法規
40K ~ 50K TWD / month
2 years of experience required
No management responsibility
