电生理公司招聘RA专员-坐标北京经济技术开发区
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
PositionTitle:Regulatory Affairs Specialist
Department:RA
MDT System Title:
ReportsTo: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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