北京 [切换城市] 北京招聘北京质量管理/安全防护招聘北京认证工程师/审核员招聘

Regulatory Affair Supervisor

上海猎英人才服务有限公司

  • 公司规模:少于50人
  • 公司性质:民营公司
  • 公司行业:中介服务

职位信息

  • 发布日期:2012-11-02
  • 工作地点:北京
  • 招聘人数:1
  • 工作经验:五年以上
  • 学历要求:本科
  • 语言要求:英语熟练
    英语熟练
  • 职位月薪:10000-14999
  • 职位类别:体系工程师/审核员  认证工程师/审核员

职位描述

Education

? At least an ordinary degree in a science or technology discipline.

Experience

? Experience with class I, II and III medical devices and IVDs registration in China, including imported and local manufactured in Beijing.

? Experience with medical devices and IVDs' clinic trial investigation operation and organization

Duties & Skills

? Skillful in SFDA's medical device and IVD regulations and registration procedures.

? Skillful in the clinic trial investigation operation, the communication with hospitals, marketing teams and manufacturers

? Skillful in Beijing FDA's medical device and IVD regulations and registration procedures.

? Preparation and gathering materials needed to support submissions as directed to the relevant state authorities (SFDA, AQSIQ, Health, Agriculture, Environmental, etc.).

? Good English for both written and verbal communication

? Translation of material into Chinese when needed

? Work with R&D and technical teams to gather the required data and information both within and external to China.

? Presentation of submission material to state authorities

? Provide same day follow-up and timely answers to any questions raised by the state authorities concerning the submission.

? Provide regular reports on the status of submissions with projected approval dates

? Archive and file all submissions, certification and approval materials

? Check on the validity of certifications and approvals

? Renew certifications as required and directed.

? Travel within China will be required to visit Thermo Fisher Scientific sites, suppliers, testing laboratories and customers

? From time to time international travel may be required for individual projects with host business units.



Email:hellen.zhang@eagleconsulting.cn

公司介绍

We are a boutique staff selection firm specialized in automotive, electrical/electronics, chemical, mechanical, engineering sectors. Our consultants and researchers all possess active track record in the staff selection business. We have continuously and successfully served multinational and sizeable local enterprises for their recruitment needs.
 
Our market positioning is clear that we are good at identifying middle level management and professional staff. We believe that a strong middle level is the key of business sustainability and development for all companies. Our years of experience in the staff selection industry give us thorough understanding on how to match the needs of employers and the advantages of candidates. We provide “no-frills” while focused services that is time and cost effective to both employers and ourselves.
 
We are in association with Recruit Holdings; a Hong Kong listed company that operates ***************, a leading recruitment portal in Shanghai. The shared resources enable us to access to a broader spectrum of candidates.

联系方式

  • Email:dan.zhu@eagleconsulting.cn
  • 公司地址:天津市市区