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:

REGULATORY & QUALITY ASSURANCE ENGINEER / SUPERVISOR

Job level Middle
Work exp Minimum 4 Years
Education Bachelor Degree
Location
Within Hong Kong
Employment type Full Time
Benefits 5-day week
Industry Medical services / Pharmaceutical
Job function Information Technology > Technical Writing / Consulting
Legal / Professional Services > Legal & Compliance
Manufacturing > Quality Assurance / Control
Published On 27/02/2019

工作職責Job responsibility:

(主要工作內容)

  • 網站更新
  • 會員資格維護
  • 內審
  • 不良事件系統維護
  • CE技術文件歸檔
  • 醫療器械產品分類界定
  • 國內註冊產品註冊資料申報
  • 註冊檢驗
  • 臨床試驗
  • NB審核協助
  • 進口註冊產品註冊協助
  • 市場銷售支持
  • 檢驗報告歸檔
  • 上級領導臨時安排的工作

(權限管理)

  • 本職責所擁有的權限
  • 公司官網
  • 網站
  • 不良事件上報系統
  • 分類界定網站
  • 省局行政審批上報系統
  • 臨床機構
  • 代理機構
  • 網站
  • GOA


基本條件Fundamental qualification:

  • 性別:不限;
  • 習性:無不良喜好.
  • Sex: unlimited;
  • Habits: no bad taste.



知識水平Knowledge:

  • 本科學歷以上;
  • 英語六級以上。
  • Bachelor degree or above in human resource management major;
  • CET-6 or above.



工作技能Work skills:

  • 獨立領導項目工作的能力;
  • 較強的對外溝通能力;
  • 熟悉公司產品的開發操作流程;
  • 有較強的分析能力、應變能力和組織協調能力;
  • 較強的口頭、書面表達能力;
  • 英語讀、寫能力熟練;
  • 熟練使用Office辦公軟件和AutoCAD軟件。
  • The ability to carry out their work independently;
  • Strong external communication capability;
  • Familiar with development of company’s production progress;
  • Strong analytical skills, adaptability, and organizational coordination;
  • Strong oral and written expression.;
  • Good at English reading and writing;
  • Good skills in Office-software and AutoCAD .

 

工作經驗Work experiences:

  • 4年以上制造型企業工作經驗,有外資企業工作經驗者優先;
  • 有醫療器械註冊經驗者優先;
  • 有GMP,ISO13485質量體系審核經驗,或有內審員資格證者優先。
  • Working experience in manufacturing foreign-invested enterprises for at least 4 year;
  • Medical device registration working experience is preferred;
  • GMP, ISO 13485 quality system or certified quality management system auditor is preferred.


其他要求Other demands:

  • 性格開朗且不失穩重;積極主動;樂觀向上;
  • 具有很強的判斷能力,計劃和執行能力;
  • 嚴謹細致;
  • 充沛的精力。
  • Cheerful personality and does not lose the steady; active, optimistic upward;
  • Has a stronge capacity for diagnosis, planning and implementation capacity;
  • Meticulous and precise;
  • abundant energy.


Candidates with less experience will be considered as Regulatory & Quality Assurance Engineer
Required to station in Dongguan factory and Shenzhen office 5 days per week.

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 via [ ].