崗位職責(zé)：
1.?Class?II?Medical?Device?RA?in?China
Keep?closely?communication?with?NMPA(CFDA)?and?government,?update?the?regulation?requirement?to?local?management?and?cooperate?quality?department?to?coordinate?for?implementation.?
1.?中國二類醫(yī)療器械相關(guān)法律法規(guī)
-?與食品藥品監(jiān)督管理局等相關(guān)政府部門保持密切聯(lián)系，將法律法規(guī)及相應(yīng)標(biāo)準(zhǔn)的更新情況及時匯報給蘇州管理層及集團(tuán)質(zhì)量部門，并協(xié)調(diào)在公司內(nèi)實(shí)施
-Work?together?with?cooperate?RA?team?to?ensure?the?national?regulation?and?standards?are?fulfilled.
-?與集團(tuán)法規(guī)部門聯(lián)絡(luò)，協(xié)調(diào)中國相應(yīng)法規(guī)及標(biāo)準(zhǔn)要求的實(shí)施。
-Offer?the?support?to?R&D?during?the?new?product?design?phase?to?ensure?the?national?regulation?and?standards?fulfilled.
-?提供新產(chǎn)品研發(fā)的法規(guī)支持，確保新產(chǎn)品符合中國相應(yīng)法規(guī)/標(biāo)準(zhǔn)要求。
2.?Familiar?with?other?international?regulation?for?medical?device,?e.g.?MDR,?QSR?,?JPAL,?KGMP,?etc.
2.?熟悉其他國家醫(yī)療器械法規(guī)，如，歐盟MDR，美國QSR，日本?JPAL，韓國?KGMP等。
3.?Set?up?the?complete?and?effective?RA?system,?provide?the?compliance?assessment.?Offer?the?training?or?sharing,?improve?the?RA?awareness?for?all?employees?to?ensure?the?RA?compliance?in?whole?company
3.?建立完善醫(yī)療器械法規(guī)管理體系，提供法規(guī)符合性評估。?提供適當(dāng)?shù)呐嘤?xùn)或分享，提高全體員工滿足法規(guī)要求的意識，確保合規(guī)。
4.?QMS?support?on?ISO?9001/13485
4.?ISO?9001/13485?質(zhì)量管理體系支持。
崗位要求：
1.?University?graduates?or?above?in?Mechanical?Engineering,?Electronic?Engineering?or?their?equivalent;
1.?大學(xué)本科或以上學(xué)歷，主修機(jī)械或電子工程或相關(guān)專業(yè)；
2.?At?least?5?years’experience?on?RA?of?class?II?medical?device;?familiar?with?internal?medical?device?regulations,?familiar?with?ISO9001/13485;
2.?五年以上二類醫(yī)療器械法規(guī)工作經(jīng)歷，熟悉其他國外醫(yī)療器械相關(guān)法規(guī)，熟悉ISO9001/13485要求。
3.?good?communication?skill?and?fluent?in?English.
3.良好的英語水平和溝通能力.