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工作職責Responsibilities:
1、負責醫(yī)療器械國際市場準入和注冊工作；
To undertake the medical device registration works in International area；
2、負責相關(guān)區(qū)域的醫(yī)療器械法規(guī)的研究分析和導入、產(chǎn)品注冊資料的編寫、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、負責醫(yī)療器械注冊過程中與注冊顧問及相關(guān)監(jiān)管機構(gòu)的聯(lián)絡(luò)溝通；解決注冊問題，推進注冊進程、保證良好注冊結(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、自動化類理工科專業(yè)背景，生物醫(yī)學工程專業(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)注冊相關(guān)工作經(jīng)驗優(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隊合作精神，抗壓能力強；
Excellent communication skills with team work spirit; ability to maintain good performance under pressure；
4、良好的英語讀寫能力；
Good communication skill includes English in reading/writing and oral。