Job Description
TheRegulatoryAffairsPrincipalisresponsibleforpostmarketactivitiesforAdministrationandSafetySystemmedicaldevices.Thisroleinfluencesdepartmentregulatoryprocessesandprocedures,supportingstrategiesforworldwidePMSactivities.KeyresponsibilitiesincludeleadingprojectsinsupportofproductPostMarketactivities,AdverseEventReporting,anddeviceriskmanagementthroughoutvariousstagesofdesignanddevelopmentofAdministrationandSafetySystems.bKeyResponsibilities:/bbrulbrliAccountableforGlobalPostMarketSurveillanceandVigilanceActivitiesforAdministrationandSafetySystemmedicaldevicesinWest'sportfolio./librliSupportestablishmentandmaintenanceofprocedures,workinstructions,andtemplatesassociatedwithPostMarketactivities./librliExecutepost-marketsurveillanceplansinthecommerciallifecycleincludingperiodicreviewandreportingrequirements./librliCollaboratewithcross-functionalteammembersincollecting,analyzing,trending,andreportingonsafetyandperformancedatatoidentifypotentialadversesafetyrisksorperformancetrends./librliResponsibleforcomplaintmonitoringandadverseeventreportingglobally./librliEnsuresupportofappropriatepostmarketsurveillancerelatedsubmissionsandreportstohealthauthoritiesworldwideinaccordancewithlocalprocedures./librliLeadandsupportthecreationandstreamlineofprocessestoassureproactivesurveillance(databasesearches,literaturereviews)andreactivesurveillance(complaintshandling,fieldactions)isconductedefficiently./libr/ulbRequirements:/bbrulbrliEducation:Bachelor's,master'sdegreeinnursing,engineeringorrelateddiscipline./librliExperience:Bachelor'swith10-12years;Master'sdegree8yearsmedicaldevice,pharmaceuticalorregulatoryexperience./librliAdvancedknowledgeofUSClassIIandEUClassIIadeviceexperience./librliAdvancedknowledgeof21CFR4/803/806/820,ISO13485,ISO14971,EUMDD(93/42/EEC)andMDR(2017/745)./librliAbilitytoworkeffectivelyinmultinational/multiculturalenvironment./librliAbilitytomanagecomplexprojectsandtimelinesinamatrixteamenvironment./librliStronginterpersonal,communication,negotiation,andpresentationskills./librliAbilitytonavigateandutilizeSAPforcomplaintprocessing./librliAbilitytoindependentlyidentifycompliancerisksandescalatewhennecessary./libr/ulbPreferredKnowledge,SkillsandAbilities:/bbrulbrliInternationalregulatorycompetency./librliAdvanceddegree./librliR.A.Ccertification(s)./librliExperiencewithadministrationanddrugdeliverysystemspreferred./libr/ulbAdditionalRequirements:/bbrulbrliAbilitytoresearch,read,analyze,andinterpretregulatoryandclinicalliteratureanddocumentation./librliAbilitytoreview,collate,describe,andsummarizescientificandtechnicaldata./librliAbilitytoorganizecomplexinformationandcombinepiecesofinformationtoformgeneralrulesorconclusions./librliAbilitytoutilizejudgmentandmakedecisionsconsideringtherelativerisksandbenefitsofpotentialactionstochoosethemostappropriateone./librliAbilitytoassess,plan,scheduleandmanagemultiplelong-termandshort-termprojects,tasks,responsibilitiesand/orprioritiesinaconcurrentfashionwithseveralparalleldeliverablesandexecutedeliverablestotime-linecommitments./librliAbilitytobeaneffectiveteammemberandworkwellwithothersinateamenvironmentoncross-functionaland/ormatrixteams./librliAbilitytobeflexiblewithchangingprioritiesandcomplywithconstantlychangingregulatoryprocedures./librliAbilitytobuildstrongrelationshipsbothinternallyandexternally./librliAbilitytoworkinafast-pacedenvironment./librliAbilitytocomprehendandapplylanguageskillstothedegreerequiredtoperformthejobbaseduponthejobrequirementslistedabove./librliAbilitytoverballycommunicateideasandissueseffectivelytootherteammembersandmanagement./librliAbilitytowriteandrecorddataandinformationasrequiredbyprocedures.