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工作職責(zé)Responsibilities:
1、負(fù)責(zé)醫(yī)療器械國(guó)際市場(chǎng)準(zhǔn)入和注冊(cè)工作；
To undertake the medical device registration works in International area；
2、負(fù)責(zé)相關(guān)區(qū)域的醫(yī)療器械法規(guī)的研究分析和導(dǎo)入、產(chǎn)品注冊(cè)資料的編寫(xiě)、收集、遞交；
To undertake the analysis and implementation of related regulations and technical standards of medical devices; writing, collecting and submitting the registration dossier；
3、負(fù)責(zé)醫(yī)療器械注冊(cè)過(guò)程中與注冊(cè)顧問(wèn)及相關(guān)監(jiān)管機(jī)構(gòu)的聯(lián)絡(luò)溝通；解決注冊(cè)問(wèn)題，推進(jìn)注冊(cè)進(jìn)程、保證良好注冊(cè)結(jié)果；
To maintain active communication with consultants, and relating authorities; solving registration problems, pushing forward the registration process and guarantee a favorable registration result。

職位要求Job Requirements:
1、電子、自動(dòng)化類理工科專業(yè)背景，生物醫(yī)學(xué)工程專業(yè)優(yōu)先；
Major in electronics, automation engineering and biomedical engineering will be preferable；
2、有醫(yī)療行業(yè)法規(guī)注冊(cè)相關(guān)工作經(jīng)驗(yàn)優(yōu)先（一類二類三類都可以）；
Working experience in medical device registration will be preferable；
3、具備良好的溝通合作的能力和團(tuán)隊(duì)合作精神，抗壓能力強(qiáng)；
Excellent communication skills with team work spirit; ability to maintain good performance under pressure；
4、良好的英語(yǔ)讀寫(xiě)能力；
Good communication skill includes English in reading/writing and oral。