崗位職責
1.Handling the process to get and maintain product registration in China, including internal communication, contact with CFDA test labs and CFDA etc.;
處理申請和保持國內醫(yī)療器械產品注冊事宜，包含內部溝通，與檢測所、藥監(jiān)局的聯系等。
2.Apply for FSC, CFDA registration for export medical device;
申請自由銷售證明，對出口醫(yī)療器械進行備案；
3.Assist in foreign product registration;
協(xié)助國外產品注冊；
4.Assist in internal and external audits;
協(xié)助提供客戶要求的注冊相關的資料；
5.Other task arranged by superior.
上司安排的其他工作。
任職要求
1.College degree or above in Science and engineering,
大專 或以上學歷，理工科專業(yè)
2.Good communication skill and team work spirit
良好的溝通能力及團隊精神
3.Certified auditor of ISO13485 is prefer
有ISO13485內審員資格證書尤佳
4.Experienced in CE/FDA registration is prefer
有CE/ FDA醫(yī)療器械注冊經驗者優(yōu)先
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