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电生理公司招聘RA专员-坐标北京经济技术开发区

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发表于 2023-3-28 14:02:54 | 显示全部楼层 |阅读模式

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电生理医疗器械公司,坐标 北京经济技术开发区
产品涉及:心脏冷冻消融设备及导管、心脏电生理标测导管、消融导管、房间隔穿刺器械、心腔内超声导管等
招聘岗位:RA专员,负责中国和国际区域
感兴趣请联系:18101131862

JobDescription
  
Position  Title:
  
  
Regulatory Affairs Specialist
  
  
Department:
  
  
RA
  
  
MDT System Title:
  
  
  
  
Reports  To:
  
  
Senior RA Manager
  

MAIN JOBDUTIES/RESPONSIBILITIES:

  • Performs coordination and preparation of     document packages for regulatory submissions from all areas of company,     internal audits and inspections.
  • Leads the 3rd party type testing in     China’s domestic testing lab and get the testing reports on schedule.
  • Leads or compiles all materials required in     submissions, license renewal and annual registrations.
  • Recommends changes for labeling,     manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Leads the regular maintenance of the latest China     regulations, guidance, standards, and spread to cross functional team for     the implementation.
  • Keeps abreast of regulatory procedures and     changes.
  • May direct interaction with regulatory     agencies on defined matters.
  • Recommends strategies for earliest possible     approvals of clinical trials applications.
  • Familiar with CE MDR, FDA 510k/PMA, Japan MHLW     regulation is preferred.


REQUIREMENTS:

  • Bachelors degree required
  • Minimum of 3 years of relevant experience, or     advanced degree with a minimum of 5 years relevant experience


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