职责描述:Mainlyresponsibleformolecularproductsandcompaniondiagnosticproducts(CDx)Compileregistrationdossierandprepareotherregulatorydocuments,andmakesureproductregistrationtobefinishedtimelyandsuccessfully.Communicateinternalandexternalonproductregistrationissues.AssistmanagerincheckingIFUs,labels,SOPs.Properlymaintainlicenses,reports,andregistrationdocuments.Collectandupdaterelevantregulations,standardandtechnicalguidance.AssistinRAtasks/activitiesassigned任职要求:Bachelor’sdegreeoraboveinBiochemistry,BiologyorMedicalexamination(Molecularbiologyfirst)FluentEnglishinverbalandwritten,veryimportant.2~3+yearsrelevantexperienceinmedicaldevice,orbiologicsindustrywillbepreferred.Wellknowprofessionalknowledgeonregulatoryaffairsregulation:Chineseregulations,internationalguidelineSelf-motivatedwithgoodcommunicationskillandteamspirit;willingtoworkunderpressure.GoodskillsinstandardPCsoftware.语言要求:不限
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