產(chǎn)品注冊(cè)主管崗位職責(zé)
醫(yī)療器械產(chǎn)品(進(jìn)口)注冊(cè)主管四川科瑞德制藥股份有限公司四川科瑞德制藥股份有限公司,科瑞德制藥,科瑞德一、崗位職責(zé):
1.負(fù)責(zé)提供醫(yī)療器械產(chǎn)品立項(xiàng)、申報(bào)及上市后產(chǎn)品的法規(guī)技術(shù)支持;
2.負(fù)責(zé)公司醫(yī)療器械產(chǎn)品相關(guān)資質(zhì)文件的辦理;醫(yī)療器械產(chǎn)品注冊(cè)申報(bào)資料的整理、審核,醫(yī)療器械產(chǎn)品注冊(cè)工作的實(shí)施;跟進(jìn)項(xiàng)目進(jìn)度,確保注冊(cè)申報(bào)工作順利進(jìn)行;
3.及時(shí)跟蹤法規(guī)信息、國(guó)內(nèi)外相關(guān)產(chǎn)品信息;
4.搭建內(nèi)外部溝通橋梁,關(guān)注產(chǎn)品研發(fā)技術(shù)及注冊(cè)法律法規(guī)的最新動(dòng)態(tài),維護(hù)與藥監(jiān)、注冊(cè)機(jī)關(guān)等政府部門關(guān)系,樹(shù)立良好的公司形象;
5.完成領(lǐng)導(dǎo)交辦的其它申請(qǐng)事項(xiàng)。
二、任職要求:
1.具有三年以上醫(yī)療器械注冊(cè)申報(bào)工作經(jīng)驗(yàn),熟悉醫(yī)療器械相關(guān)政策法規(guī)、技術(shù)要求及工作流程;有成功申報(bào)并獲批經(jīng)驗(yàn)證者優(yōu)先;
2.有獨(dú)立操作進(jìn)口有源醫(yī)療器械注冊(cè)經(jīng)驗(yàn)者優(yōu)先;
3.英語(yǔ)水平6級(jí)以上,能獨(dú)立查閱國(guó)內(nèi)外相關(guān)文獻(xiàn)及有優(yōu)秀的英語(yǔ)讀寫聽(tīng)說(shuō)能力,以及較強(qiáng)的文字撰寫能力;
4.工作認(rèn)真負(fù)責(zé)、積極主動(dòng)、嚴(yán)謹(jǐn)及高效;責(zé)任心強(qiáng),勇于承擔(dān)責(zé)任,挑戰(zhàn)自我,有團(tuán)隊(duì)建設(shè)能力,有合作精神。
篇2:IVD注冊(cè)主管崗位職責(zé)IVD注冊(cè)主管職責(zé)任職要求
IVD注冊(cè)主管崗位職責(zé)
高級(jí)注冊(cè)專員/主管-IVD丹納赫丹納赫(上海)企業(yè)管理有限公司,丹納赫LeicaBiosystemsisagloballeaderinworkflowsolutionsandautomation,integratingeachstepintheworkflow.Astheonlycompanytoowntheworkflowfrombiopsytodiagnosis,weareuniquelypositionedtobreakdownthebarriersbetweeneachofthesesteps.Ourmissionof“AdvancingCancerDiagnostics,ImprovingLives”isattheheartofourcorporateculture.Oureasy-to-useandconsistentlyreliableofferingshelpimproveworkflowefficiencyanddiagnosticconfidence.
FUNCTION:ThispositionwillhaveresponsibilitytosupportregulatorydatabasesmaintenanceandSOPestablishment,Chineselabeling,ProductRegistration,aswellascoordinateproductpost-marketingsurveillanceinChinatomeetregulationcompliance.
ESSENTIALDUTIESANDRESPONSIBILITIES:
Theincumbentwillalsoberesponsiblefor,butnotlimitingtothefollowingduties:
?Implementlocaltypetesting;
?PrepareandsubmitproductregistrationdocumentsforClassI,II,IIIproducts;
?DraftandreviewChineselabelsandusermanuals;
?Providetheregulatorysupporttocross-functionalteamwithinandoutsideChina;
?Workwithindividualdivisionstoprovidenecessarysupporttodealersandcustomersforregulatorycompliance;
?Collect,analysisandlookforthecountermeasureforthenewreleasedregulation;
?Supporttheregulatorydatabasesmaintenance,updatethedatabasestimely.
Thisdescriptionisasummaryofprincipleresponsibilitiesandisnotintendedtoincludealldutiesmaybeassigned.
WORKINGRELATIONSHIPSANDCONTACTS:
?ExternalcontactsforthispositionincludeCFDAofficials,dealersandusers/customers,localtestingcenter,
?Internalcontactsincludeheadquarter,marketingteam,logisticteam,applicationandsales/serviceteam,QA
ESSENTIALQUALIFICATIONS:
EDUCATION&SKILLS:
?Bachelordegreeorabove
?GoodEnglishandChineselanguageskills
WORKINGEXPERIENCE:
?Thispositionrequires:
?Forsupervisor:atleast3yearsworkingexperienceinIVDindustry
?ForSr.specialist:atleast2yearsworkingexperienceinIVDindustry.
FUNCTIONALCOMPETENCIES:
?HaveknowledgeinCFDAregulationofmedicaldevicesand/orIVDandinCFDAregistrationprocess;
?Excellentteamworkandinterpersonalcommunicationskill;
?Goodattitude,wellhabitofwork,positive&takeresponsibility;
?Willingtofocusondetailedroutinework.
TRAVELREQUIREMENTS:
Thispositionmayrequirebusinesstravelinginafewnesssituation.
WORKENVIRONMENT:
Thispositionfunctionsinageneralofficeenvironment.
篇3:注冊(cè)部主管崗位職責(zé)注冊(cè)部主管職責(zé)任職要求
注冊(cè)部主管崗位職責(zé)
崗位職責(zé):
1、依據(jù)公司戰(zhàn)略發(fā)展規(guī)劃,組織制定注冊(cè)年度發(fā)展規(guī)劃,保障注冊(cè)工作有序進(jìn)行;
2、依據(jù)國(guó)家有關(guān)注冊(cè)工作法律法規(guī),組織起草、制定、修訂注冊(cè)部相關(guān)管理制度,組織制定、完善部門內(nèi)部與外部銜接相關(guān)業(yè)務(wù)流程,并監(jiān)督落實(shí)和執(zhí)行,以確保流程順暢和可操作性;
3、組織申報(bào)國(guó)家、省市級(jí)各類科技項(xiàng)目、基金、獎(jiǎng)項(xiàng)及榮譽(yù)申報(bào),獲取科技資金支持,降低研發(fā)成本;
5、與各級(jí)知識(shí)產(chǎn)權(quán)部門溝通、合作,獲取知識(shí)產(chǎn)權(quán)相關(guān)政策、信息,挖掘知識(shí)產(chǎn)權(quán)點(diǎn);
任職要求:
1、本科以上學(xué)歷;
2、對(duì)國(guó)、內(nèi)外高耗材產(chǎn)品注冊(cè)能夠指導(dǎo)下屬進(jìn)行工作;
4、溝通、應(yīng)變能力強(qiáng),有較強(qiáng)的文字功底。崗位職責(zé):
1、依據(jù)公司戰(zhàn)略發(fā)展規(guī)劃,組織制定注冊(cè)年度發(fā)展規(guī)劃,保障注冊(cè)工作有序進(jìn)行;
2、依據(jù)國(guó)家有關(guān)注冊(cè)工作法律法規(guī),組織起草、制定、修訂注冊(cè)部相關(guān)管理制度,組織制定、完善部門內(nèi)部與外部銜接相關(guān)業(yè)務(wù)流程,并監(jiān)督落實(shí)和執(zhí)行,以確保流程順暢和可操作性;
3、組織申報(bào)國(guó)家、省市級(jí)各類科技項(xiàng)目、基金、獎(jiǎng)項(xiàng)及榮譽(yù)申報(bào),獲取科技資金支持,降低研發(fā)成本;
5、與各級(jí)知識(shí)產(chǎn)權(quán)部門溝通、合作,獲取知識(shí)產(chǎn)權(quán)相關(guān)政策、信息,挖掘知識(shí)產(chǎn)權(quán)點(diǎn);
任職要求:
1、本科以上學(xué)歷;
2、對(duì)國(guó)、內(nèi)外高耗材產(chǎn)品注冊(cè)能夠指導(dǎo)下屬進(jìn)行工作;
4、溝通、應(yīng)變能力強(qiáng),有較強(qiáng)的文字功底。