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療器械產品注冊事宜,包含內部溝通,與檢測所、藥監局的聯系等。
2.Apply for FSC, CFDA registration for export medical device;
申請自由銷售證明,對出口醫療器械進行備案;
3.Assist in foreign product registration;
協助國外產品注冊;
4.Assist in internal and external audits;
協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, at least 1 year related working experience in CFDA active medical devices registration.
大專 或以上學歷,理工科專業,1 年或以上CFDA有源醫療器械注冊工作經驗;
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醫療器械注冊經驗者優先
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