Job ref no.: CT3118200-01#7806

RA主 管

Vincent Medical Manufacturing Co., Limited

Benefits
  • 5-day week

職位編號 Position number: RA001   

所屬部門 Department: 法規事務部

直屬上級Immediate superior: QA/RA Manager    

直屬下級Immediate Subordinate: DCC專員、RA專員DCC Specialist/ RA Coordinator    

下級人數Number of Subordinate: 4
 

工作概要Summary of Job:

  • 主持公司產品法規註冊,法規法律知識培訓,應對監管部門調查,認證檔案建立事宜。
  • In charge of registration for the company's product and prepare responses to queries from regulatory authorities, organization of the training about  Rules and Regulations, establishment of certification documents.

 

工作職責Job responsibility:

(主要工作內容)

  • 完成公司產品的國內外法規註冊,獲取必要的證書及許可檔
  • 負責DCC工作的正常運行,完善部門內管理制度
  • 主持公司內審
  • 提供客戶法規諮詢
  • 認證檔案文書的建立、匯總工作
  • 程式檔的維護
  • 外審活動的支持
  • 應對監管部門的監督管理
  • 普及法律法規知識
  • GMP的貫徹與實施
  • 保持跟監管部門的關係
  • 上級領導臨時安排的工作 

(許可權管理)

  • 本職責所擁有的許可權
  • 省局行政審批上報系統
  • 內部網/資料庫/伺服器
  • 國外網站
  • 內部網/伺服器
  • GOA

 

Attractive remuneration package is provided to the right candidate, including 5 day work, incentive bonus & medical insurance. Interested parties please send your full resume with CURRENT and EXPECTED salary to Apply Now.

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More job information
Job ref no. CT3118200-01#7806
Salary
  • N/A
Job Function
Industry
Employment Term
  • Full-time
Experience
    N/A
Career Level
  • Non-management level
Education
  • N/A