MAIN RESPONSIBILITIES:Regulatory AffairsHandleall Registrationrequirement ofMedicalDevicewiththeMedical DeviceAuthority (MDA)LiaisonwithappointedComformityAssessmentBody(CAB)inplanningforproduct verificationLiaisewithlocal andglobal RegulatoryAffairs personneltoensurecompliancewith product registrationOn atimely basis,prepareor arrange for preparation,the Regulatory budgets,reports and forecastsDelivermonthlyreportforallregulatoryactivitiesandstatusreportonregistrationtoTop ManagementProvideregulatorysupporttoallrelevantAbbottDiagnostic'sdepartmentinorderto achieve commercial plan goalwithinMalaysiaProvidetimelyinformationregardingMalaysia'slegislationto managementto ensure continuous Regulatory complianceQuality AssuranceEnsurecomplianceto Malaysia's QualitySystemas per statedin the ADD Divisional proceduresandGoodDistribution PractiseMedical DeviceToActasQualityRepresentativeandfacilitatebothInternalandExternalAuditsTocarry outPostMarketSurvellianceandMandatory Problem Reporting timelyas per local and global requirmentsFacilitateclosureof CAPAwith functionalownersforobservationbyinternalandor external auditorsManage all local distributors as per divisional documents;Commercial Affiliate - Warehousing Storage and Distribution ProcessesManageallAbbottDiagnocticsPurchasingandSupplierControlProcessesasper stated in the divisional proceduresDeploymentofTrainingofDivisionProceduretorelevantemployeestoensure guidelines are followed.To work functional heads, anddraw upTraining Plan for respective employees,and ensure timely completion oftrainingKeyuserforSBMtoolsforbothCAPAandDistributorControlMaintenanceofSiteMasterFile/RegulatoryCompliancemanualEDUCATION/ EXPERIENCE:Degree in Biomedicl Sciences/Bachelorin Science/Medical Laboratory Technology/PharmacyDemonstrate strong attention to details and communicationskills (writing/verbal) in EnglishDemostrateabilitytoworkinamultidisciplinaryenvironmentandadapttoavarietyof projects/businessneedsGoodDocumentationPractice ?