上市后监督总监微创医疗器械上海微创医疗器械(集团)有限公司,microport,微创医疗,微创医疗器械,微创ThisnewpositionofDirector,PostMarketSurveillance(PMS)isaccountableforoverallstrategy,executionandoversightofallactivitiesassociatedwithcomplainthandlingassociatedqualitymanagementsystems,functionsandregulatorycompliancereportingofAdverseEvents(AEs)andMedicalDeviceReportable(MDRs)throughouttheproductlifecycleforMicroPortCardiovascularbusiness,globally.

•Thiskeyleadershiproleistoensuregovernmentalregulatoryrequirementsaremet,customerexperiencesareappropriatelyloggedandinvestigatedtobothcomplywithlaws/regulations.Thispositionwillfacilitateproactivequalityandassociatedimprovementsincustomerexperience,aswellastoensuretheorganizationisinformedofadversetrendingthroughanalysisofcomplaintsforAdverseEvents,MedicalDeviceReportable,includingtrackingandtrending.

•Directleadershipaccountabilityandoversightofactivitiessuchas(a)uptakeandloggingofcustomercomplaints,(b)theirproperandthoroughinvestigationandsubsequentdocumentation,(c)statisticaltrackingandtrendingandassociatedevaluationandescalationofadversecustomercomplainttrendsandearlyidentificationofnewissues(withpriorityonsafetyissues),(d)properevaluationofsafetyandpatientriskthroughoveralladministrationofaHealthHazardEvaluation(HHE)process,and(e)AEandMDRreporting,andtheassociatedtimeliness.

•AssurescompliancewithregardstoAE/MDRwiththeapplicableinternationalregulatoryrequirements(ie,FDAQSRs,ISO13485,JapaneseMHLW,BrazilianANVISA,EUMDR)forthecompany'sproducts,includingmedicaldevices,andcombinationproducts.Ensuressuccessfulinternalandexternalinspectionsandaudits.

•Ensuretimelinessofallcomplainthandling,adverseevents,andmedicaldevicereportingactivitiesinaccordancetoprocedures,standardsandregulations.

•ResponsibleandaccountableforthecomplianceofallPMSprocessesandprocedures,associateddocumentandperformancemetrics.