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(nèi)醫(yī)療器械產(chǎn)品注冊事宜,包含內(nèi)部溝通,與檢測所、藥監(jiān)局的聯(lián)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(chǎn)品注冊;
4.Assist in internal and external audits;
協(xié)助提供客戶要求的注冊相關(guān)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(xué)歷,理工科專業(yè),1 年或以上CFDA有源醫(yī)療器械注冊工作經(jīng)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(nèi)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(jīng)驗者優(yōu)先
聯(lián)系我時,請說是在吉安人事人才網(wǎng)上看到的,謝謝!