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產(chǎn)品注冊(cè)主管崗位職責(zé)

2024-07-31 閱讀 7836

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。