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(qǐng)和保持國(guó)內(nèi)醫(yī)療器械產(chǎn)品注冊(cè)事宜，包含內(nèi)部溝通，與檢測(cè)所、藥監(jiān)局的聯(lián)系等。
2.Apply for FSC, CFDA registration for export medical device;
申請(qǐng)自由銷(xiāo)售證明，對(duì)出口醫(yī)療器械進(jìn)行備案；
3.Assist in foreign product registration;
協(xié)助國(guó)外產(chǎn)品注冊(cè)；
4.Assist in internal and external audits;
協(xié)助提供客戶要求的注冊(cè)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(zhuān) 或以上學(xué)歷，理工科專(zhuān)業(yè)，1 年或以上CFDA有源醫(yī)療器械注冊(cè)工作經(jīng)驗(yàn)；
2.Good communication skill and team work spirit
良好的溝通能力及團(tuán)隊(duì)精神
3.Certified auditor of ISO13485 is prefer
有ISO13485內(nèi)審員資格證書(shū)尤佳
4.Experienced in CE/FDA registration is prefer
有CE/ FDA醫(yī)療器械注冊(cè)經(jīng)驗(yàn)者優(yōu)先
聯(lián)系我時(shí)，請(qǐng)說(shuō)是在臨沂招聘網(wǎng)上看到的，謝謝！