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。

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.