**MAIN RESPONSIBILITIES:** Regulatory Affairs + Handleall Registrationrequirement ofMedicalDevicewiththeMedical DeviceAuthority (MDA) + LiaisonwithappointedComformityAssessmentBody(CAB)inplanningforproduct verification + Liaisewithlocal andglobal RegulatoryAffairs personneltoensurecompliancewith product registration + On atimely basis,prepareor arrange for preparation,the Regulatory budgets,reports and forecasts + DelivermonthlyreportforallregulatoryactivitiesandstatusreportonregistrationtoTop Management + ProvideregulatorysupporttoallrelevantAbbottDiagnostic'sdepartmentinorderto achieve commercial plan goalwithinMalaysia + ProvidetimelyinformationregardingMalaysia'slegislationto managementto ensure continuous Regulatory compliance Quality Assurance + Ensurecomplianceto Malaysia's QualitySystemas per statedin the ADD Divisional proceduresandGoodDistribution PractiseMedical Device + ToActasQualityRepresentativeandfacilitatebothInternalandExternalAudits + Tocarry outPostMarketSurvellianceandMandatory Problem Reporting timelyas per local and global requirments + Facilitateclosureof CAPAwith functionalownersforobservationbyinternalandor external auditors + Manage all local distributors as per divisional documents;Commercial Affiliate - Warehousing Storage and Distribution Processes + ManageallAbbottDiagnocticsPurchasingandSupplierControlProcessesasper stated in the divisional procedures + DeploymentofTrainingofDivisionProceduretorelevantemployeestoensure guidelines are followed. + To work functional heads, anddraw upTraining Plan for respective employees,and ensure timely completion oftraining + KeyuserforSBMtoolsforbothCAPAandDistributorControlMaintenanceofSiteMasterFile/RegulatoryCompliancemanual **EDUCATION/ EXPERIENCE:** + Degree in Biomedicl Sciences/Bachelorin Science/Medical Laboratory Technology/Pharmacy + Demonstrate strong attention to details and communicationskills (writing/verbal) in English + Demostrateabilitytoworkinamultidisciplinaryenvironmentandadapttoavarietyof projects/businessneeds + GoodDocumentationPractice ​ An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com