电生理公司招聘RA专员-坐标北京经济技术开发区

RA小编辑

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