岗位职责
1.Handling the process to get and maintain product registration in China, including internal communication, contact with CFDA test labs and CFDA etc.;
处理申请和保持国内医疗器械产品注册事宜，包含内部沟通，与检测所、药监局的联系等。
2.Apply for FSC, CFDA registration for export medical device;
申请自由销售证明，对出口医疗器械进行备案；
3.Assist in foreign product registration;
协助国外产品注册；
4.Assist in internal and external audits;
协助提供客户要求的注册相关的资料；
5.Other task arranged by superior.
上司安排的其他工作。
任职要求
1.College degree or above in Science and engineering, at least 1 year related working experience in CFDA active medical devices registration.
大专 或以上学历，理工科专业，1 年或以上CFDA有源医疗器械注册工作经验；
2.Good communication skill and team work spirit
良好的沟通能力及团队精神
3.Certified auditor of ISO13485 is prefer
有ISO13485内审员资格证书尤佳
4.Experienced in CE/FDA registration is prefer
有CE/ FDA医疗器械注册经验者优先
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