To cope with the growth of the business of the HK listed company, we cordially invite high caliber with energetic talents to join us on this position:

To cope with the growth of the business of the HK listed company, we cordially invite high caliber with energetic talents to join us on this position:

RA主管

Job level Middle
Location
Within Hong Kong
Employment type Full Time
Benefits 5-day week
Industry Manufacturing - Others
Job function Engineering > Engineering Project Management
Manufacturing > Quality Assurance / Control
Manufacturing > Others
Published On 12/01/2019

 

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 .