北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京医疗器械注册招聘

RA运营专员

美敦力中国

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:医疗设备/器械

职位信息

  • 发布日期:2019-07-19
  • 工作地点:北京
  • 招聘人数:若干人
  • 工作经验:无工作经验
  • 学历要求:招若干人
  • 语言要求:不限
  • 职位类别:医疗器械注册

职位描述

JOB DESCRIPTION JOB TITLE: Associate Regulatory Affairs Operation Specialist

DEPARTMENT: Regulatory Affairs

REPORTS: Manager, Regulatory Affairs


MAIN PURPOSE OF JOB 

To carry out all necessary RA related work to ensure the normal functioning of SAP GTS module & Chinese labelling system

 To provide full support on registration license maintain to Regulatory Affairs Department


MAIN JOB DUTIES/RESPONSIBILITIES

 Daily operation on SAP GTS module, including UPN&CFN export &upload ,GTS license creation, Block release on no license covered products, GTS module maintenance and improvement, UPNs searching in GTS, code of manufacturing site searching in GTS, Product importation record searching.

 Daily operation on Chinese labelling system, including license information input, UPN &CFN uploading, RA related labeling system maintenance and improvement, license information checking.

  IFU information maintenance, including providing CFDA approved IFU to BU for printing and using, providing regulatory support and instruction to related departments on IFU using. Ensure the accuracy of IFU record in Chinese labelling system. Assist to create linkage between license/Model number and relative materials about products in Chinese labelling system.

 Provide broad support to registration teams including license database in J drive maintenance, training on SAP GTS module & Chinese labelling system for new RA Specialist.

 Cooperate with other departments and follow up some projects.

 Other duties as directed.


QUALIFICATIONS REQUIREMENTS

 College degree

 Professional written and oral communication skills in English and Chinese.

 High scenes of work quality, looking into details.

 Well verse in Excel, Word and PowerPoint and general computer skills. 

 Effective interpersonal communication skill Highly initiative and good team player

职能类别: 医疗器械注册

关键字: RA运营

公司介绍

About Medtronic
Together Medtronic and Covidien are working to improve how healthcare addresses the needs of more people, in more ways and in more places around the world. As one company, we can accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. This is the ideal opportunity to join us, and be part of our commitment to the health of others.

We know the combined resources of Medtronic and Covidien will be transformative, creating new methodologies and new opportunities. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Medtronic is a $27.8b company with more than 85K employees in more than 160 countries.

联系方式

  • 公司地址:北京