崗位職責(zé)
KEY RESPONSIBILITIES 工作職責(zé)
1.Lead thepreparation for CE certificate changed from MDD to MDR for CE class IIa activemedical devices.
主導(dǎo)CE 有源IIa類(lèi)產(chǎn)品MDD證書(shū)轉(zhuǎn)版為MDR證書(shū)的準(zhǔn)備工作。
2. Evaluate the gapof current technical files and quality management system documents accordingthe MDR requirement and make the project plan and lead the modification.
根據(jù)新法規(guī)MDR要求，評(píng)估目前產(chǎn)品技術(shù)文檔和質(zhì)量體系文件的差距，制定項(xiàng)目計(jì)劃并主持相關(guān)修改工作。
3.The leader forthis MDD-MDR change project, work closely with the consultant, notify body,customers and relative departments and ensure to get the MDR certificate asscheduled.
作為MDD-MDR換版項(xiàng)目負(fù)責(zé)人，密切與顧問(wèn)、認(rèn)證機(jī)構(gòu)、客戶及公司各部門(mén)溝通，確保按計(jì)劃完成換證工作。
4.Other tasksassigned by management.
上級(jí)領(lǐng)導(dǎo)分配的其他任務(wù)。
QUALIFICAITON任職要求：
1.College degreeor above in Science and engineering, at least 3 year related working experiencein CE active medical devices registration.
大專(zhuān) 或以上學(xué)歷，理工科專(zhuān)業(yè)， 3 年或以上CE有源醫(yī)療器械注冊(cè)工作經(jīng)驗(yàn)；
2.Projectexperience in handling CE medical devices registration independently andfamiliar with ISO 13485 and MDD。
有獨(dú)立負(fù)責(zé)CE產(chǎn)品注冊(cè)項(xiàng)目的經(jīng)驗(yàn)，熟悉ISO13485和MDD法規(guī)。
3. Language skillsFluent in mandarin and English
語(yǔ)言能力：流利的普通話和英語(yǔ)
4.Excellentcommunication skill and team work spirit
的的溝通能力及團(tuán)隊(duì)精神
5.Skilledoperation of Office and relative software
辦公軟件和輔助軟件熟練
6.Certifiedauditor ISO13485 is prefer
有ISO13485內(nèi)審員資格證書(shū)尤佳
7. Have knowledgeof MDR requirements is prefer
了解MDR法規(guī)要求的優(yōu)先
聯(lián)系我時(shí)，請(qǐng)說(shuō)是在咸寧就業(yè)網(wǎng)上看到的，謝謝！