崗位職責(zé)
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！