Key Responsibilities注冊(cè)職責(zé) 1)Check medical device approval documents (NMPA registration certificate, PTR (product technical requirements)) according to NMPA/CMDE registration regulations. 2)Responsible for the communication with global different sites RA and engineers. 3)Make product change registration and ensure the timely milestones according to the combination with business demands which is aligned with China commercial team the registration timeline. 4)Record the communication and supporting documents during the inspection process to ensure the completeness and accuracy of the corresponding registration supporting documents. 5)Support the arranged RA team’s Registration or statistics arranged. 6)Support other RA' registration projects and other related work. 1)根據(jù)NMPA/CMDE相關(guān)注冊(cè)法規(guī)檢查醫(yī)療器械批件(注冊(cè)證、產(chǎn)品技術(shù)要求)。 2)負(fù)責(zé)和國(guó)外不同工廠的RA和工程師的溝通對(duì)接。 3)根據(jù)需求,結(jié)合和業(yè)務(wù)部門溝通好的注冊(cè)時(shí)間線進(jìn)行產(chǎn)品變更注冊(cè)。 4)記錄注冊(cè)證及產(chǎn)品技術(shù)要求檢查時(shí)的溝通及支持文件,確保相應(yīng)注冊(cè)支持文件的齊全和準(zhǔn)確。 5)部門安排的注冊(cè)或統(tǒng)計(jì)等相關(guān)工作。 6)支持其他注冊(cè)專員的注冊(cè)項(xiàng)目等相關(guān)工作。 Summary of Minimum Qualification職位要求 1)Rigorous, meticulous and patient. 2)Bachelor’s degree or above, major in medicine, biology, chemistry, etc. 3)At least 1-year medical device registration background. 4)Fluent English can be used as a working language. 1)嚴(yán)謹(jǐn)細(xì)致認(rèn)真耐心。 2)本科及以上學(xué)歷,醫(yī)學(xué)、生物學(xué)、化學(xué)等相關(guān)專業(yè)。 3)至少1年醫(yī)療器械注冊(cè)背景。 4)英語流利,可作為工作語言。