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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