Regulatory Affairs
414 open positions
-
Post Market Surveillance Recall Specialist MeritSouth Jordan, UT 12d Lead and coordinate product recalls, corrections, removals, market withdrawals, and Field Safety Corrective Actions (FSCAs) for medical devices globally.
-
Senior Software System Engineer ElektaVeenendaal 13d Define, structure, and review requirements and specifications for medical device software development and maintenance, ensuring compliance with regulations and cybersecurity standards.
-
Senior Regulatory Affairs Specialist↗ EkoRemote $138k–$138k13d Lead regulatory remediation, global market expansion, and strategy for FDA-cleared AI hardware and software platforms in cardiovascular care.
-
Senior Regulatory Business Analyst St Vincent’s Health AustraliaMelbourne, Victoria 14d Establish and implement Software as a Medical Device (SaMD) regulatory frameworks to ensure digital health products and AI solutions comply with medical device regulations.
-
Senior Engineer, Development DanaherCincinnati, Ohio, United States $110k–$110k15d Leading medical device development from concept through sustaining, solving complex engineering problems, and improving products and processes for breast cancer diagnostics.
-
Medical Device Manager↗ Curaleaf InternationalSunderland, ENG, GB 15d Lead the day-to-day management of a global medical device portfolio, overseeing new market registrations and ensuring compliance with regulatory frameworks.
-
R&D Systems III / Systèmes R-D III↗ Boston ScientificMontréal, QC, CA 15d Translates user needs into detailed design requirements and manages system specifications throughout the product development lifecycle for medical devices.
-
Product Sustaining Engineer II↗ Zimmer BiometEnglewood, CO, US $80k–$80k15d Supporting legacy medical device products in the post-launch lifecycle through regulatory compliance, documentation, design updates, and issue resolution.
-
Engineer I QA Design↗ ArthrexNaples, FL, US 15d Execute design assurance responsibilities for FDA Class I/II and EU medical devices, ensuring compliance with regulations and standards throughout the product lifecycle.
-
Medical Device Cyber Security Program Manager SentaraVirginia Beach, VA $121k–$121k15d Lead and mature the enterprise medical device security program across a multi-hospital environment to ensure devices remain secure, compliant, and aligned with clinical safety and enterprise cybersecurity requirements.
-
Intern - Regulatory Affairs LabcorpBaltimore MD $37k–$37k15d Support regulatory submissions for Next Generation Sequencing (NGS) medical devices and clinical trials in the European Union.
-
Senior Compliance Engineer AbbottUnited States - Texas - Plano $78k–$78k15d Ensures Abbott Neuromodulation implantable and wireless medical devices comply with global safety, EMC, and regulatory standards throughout the product lifecycle.
-
Senior Expert Engineering NovartisBasel (City) $94k–$94k15d Lead the development of innovative drug-device combination products, specifically autoinjectors and novel drug delivery principles like on-body injectors and inhalers.
-
PROJECT MANAGER↗ Meiban Micro Pte LtdAng Mo Kio, S00, SG 15d Lead end-to-end planning, execution, and delivery of cross-functional projects for new medical device development, clinical studies, regulatory submissions, manufacturing transfers, and market launches.
-
Human Factors Design Engineer↗ Intuitive (intuitive Surgical)Sunnyvale, CA, US 15d Lead Human Factors (HF) efforts for new and sustaining robotic-assisted surgery product development, ensuring usability, safety, and regulatory compliance for clinical caregivers.
-
Intern– Design Assurance Engineer – Colorado Springs, CO – Summer 2027 PhilipsColorado Springs, Colorado, United States $0k–$0k15d Execute laboratory studies to validate test methods and conduct design verification for medical devices.
-
-
Product Assessor for Orthopaedic (Notified Body) SgsRemote 16d Conduct technical and clinical assessments of non-active orthopaedic medical devices and review technical documentation for compliance with EU MDR and UK MDR regulations.
-
Device Development Assurance Scientist ViatrisNorthern Cross, Dublin, Ireland 16d Lead and support Risk Management activities throughout the product development lifecycle for medical devices and combination products, ensuring compliance with international standards and regulatory requirements.
-
Sales Application Engineer↗ IntegerQuakertown, PA, US 16d Triage and manage incoming Request for Quotation (RFQ) processes, develop financial models, and prepare proposals for medical device development programs.
-
Principal Security & Privacy Engineer MedtronicFridley, Minnesota, United States of America $161k–$161k16d Technical leader advancing Privacy by Design practices for connected medical devices and supporting technology systems to ensure privacy requirements are embedded throughout the product lifecycle.
-
Quality Engineer I, Post-Market Surveillance↗ BdCovington, GA, US 16d Lead and manage Post-Market Surveillance (PMS) activities to ensure product safety and regulatory compliance for medical devices.
-
-
Clinical Scientist IntuitiveSunnyvale, CA, us 16d Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) to support CE Mark applications and EU market clearance for medical devices.
-
Senior Medical Device Quality & Regulatory Engineer Flow Neuroscience ABMalmö, Sweden 17d Senior Medical Device Quality & Regulatory Engineer owning QA, QMS, and regulatory infrastructure for a neuromodulation device treating major depressive disorder.
-
Senior Product Recall Specialist MedlineMundelein, Illinois $48k–$48k17d Lead and oversee complex product recall activities, serving as a subject matter expert for FDA-regulated notifications and company-initiated recalls.
-
Global Head of Technical Regulatory & Quality (CMC, Quality & MDD) IconUK, Reading 17d Global oversight and leadership for Technical Regulatory, Chemistry, Manufacturing and Control (CMC), Quality, and Medical Device & Diagnostic (MDD) consulting services, including strategic planning for global dossiers and regulatory compliance.
-
Software Development Process Engineer / Specialist (Medical Device)↗ Siemens HealthineersRemote, US $110k–$110k17d Define, govern, and continuously improve software development lifecycle processes for medical device products to ensure regulatory compliance and efficiency.
-
-
Senior Regulatory Affairs Specialist SmithnephewMansfield, MA $102k–$102k17d Develop regulatory strategies, secure global product approvals, and ensure compliance throughout the product lifecycle for medical technologies.
-
Head of RA PDx, Greater China GehcBeiJing 17d Provide regulatory strategy and direction for product launch, premarket submissions, and postmarket compliance in the healthcare industry.
-
-
-
Operations Product Engineer, Medical Devices↗ Helen of TroyNew York, NY, US $84k–$84k18d Primary technical owner for sustaining engineering activities on consumer medical products (Braun and Vicks), ensuring they meet intended use and specification needs through test plans, validation, and documentation.
-
Senior Post-Market Surveillance Manager (m/f/d)↗ Hilo By AktiiaRemote 18d Build and run a global post-market surveillance system for a cuffless, continuous blood pressure monitor, managing complaint handling, adverse-event reporting, data trending, and governance to ensure patient safety and product quality.
-
-
-
Senior Scientist, Combination Product Characterization (Onsite) MsdUSA - New Jersey - Rahway $117k–$117k18d Hands-on device characterization and design scientist focusing on pre-filled syringe and auto injector combination product development to identify device failure risks and improvement opportunities.
-
-
Medical Device Complaint Analyst↗ Insulet CorporationGuadalajara, JAL, MX 19d Review customer inquiries to determine if they meet the definition of a medical device complaint according to global regulations, categorize cases, and maintain accurate records.
-
Senior Staff Engineer↗ Takeda PharmaceuticalsLexington, MA, US $137k–$137k21d Lead engineering operations for medical devices, ensuring quality, safety, and regulatory compliance while developing innovative solutions and test methods.
-
Risk and Compliance Senior Manager↗ Venice and Englewood Car WashRemote $137k–$137k21d Lead regulatory adherence and risk mitigation strategies for global pharmaceutical operations, ensuring alignment with FDA, EMA, ISO 13485, and ICH guidelines.
-
-
Sr Eng, Codes and Standards BaxterBangalore, Karnataka 22d Systems engineering and compliance professional responsible for product systems architecture, design control, and standards compliance for medical devices.
-
Director Human Factors & Sustaining Engineering RegeneronRENSS - TECH VALLEY, US $148k–$148k22d Lead Human Factors Engineering and Sustaining Engineering for medical device combination products, ensuring patient safety, regulatory compliance, and product performance from development through commercial lifecycle.
-
-
Regulatory, Safety & Compliance Director↗ Thermo Fisher ScientificAT 23d Leads division-level Regulatory Affairs, Product Safety, and Compliance programs for Electron Microscopy and EFA instruments to ensure global regulatory adherence and safe product lifecycle management.
-
Principal Engineer, Contract Manufacturing（首席外协制造工程师） CardinalhealthChina-Shanghai Sourcing Office, Kerry Everbright City 23d Primary technical leader managing strategic contract manufacturing partners for medical device portfolios including ECG cables, lead wires, electrodes, and wound drain products across the Asia Pacific region.
-
Staff Quality Compliance Engineer StrykerIrvine, California $103k–$103k23d Lead global regulatory compliance and standards management for medical device products across the product lifecycle.
-
Browse by specialty
AI Data AlignmentAI EngineeringAI Software EngineeringAndroid DevelopmentApplied AI StackAutomotive AndroidAutomotive EmbeddedAvionics SoftwareBackend EngineeringBackend Web QABrowser Extension DevBusiness IntelligenceC# BackendC# Full StackCloud SecurityConversational AI QACross-Platform MobileData & ETL QAE-Commerce BackendEmbedded LinuxEngineering ManagementEnterprise IntegrationEntry-Level EngineeringERP System QAField Service TechFinTech BackendGame Engine DevGenAI CloudGeneral FrontendGPU Compiler EngHardware VerificationHigh-Frequency TradingIndustrial AutomationiOS DevelopmentIT Support QAJava BankingJava EnterpriseJava FrontendJava MicroservicesMainframe DevelopmentManual Software TestingMedical Device SWML InfrastructureMobile App QANetwork FirmwareNode.js BackendNode.js Full StackPerformance TestingPHP Web DevQA LeadershipReact FrontendRobotics SimulationRPA AutomationSalesforce & Identity QASalesforce EngineeringSAP ABAPSecure Systems TestingSecurity ProductsServiceNow EngineeringSoftware EngineeringSoftware EngineeringSoftware EngineeringSoftware Engineering LeadershiTest AutomationWeb Automation QA
Agile Release ManagementAI InfrastructureAI InfrastructureAI Platform EngineeringApplication DevOpsAWS Kubernetes EngineeringAzure Cloud InfrastructureAzure DevOps EngineeringBroadcast & OSP EngineeringCarrier Network OperationsCloud InfrastructureCloud InfrastructureCloud Infrastructure EngineeriData Center FacilitiesDefense & Security PlatformsDesktop & IT HelpdeskDevSecOps & ClearanceEmbedded Linux & ASICEndpoint ManagementEngineering Systems AdministrationEnterprise Network AdministrationExecutive IT SupportFinancial Trading SystemsFintech Platform EngineeringGCP Cloud EngineeringGlobal Technical SupportHPC & Liquid CoolingHybrid Cloud SREIndustrial Automation & SCADAIntegration & RPAIT Infrastructure LeadershipIT Service ManagementLinux Systems EngineeringMainframe & MiddlewareManaged Cloud OperationsModern Workplace CollaborationNetwork Automation & SDNObservability EngineeringOpenShift & Container PlatformPhysical Infrastructure ProjectsPlatform EngineeringPublic Sector DevOpsSAP Basis AdministrationServiceNow Platform EngineeringSite Reliability EngineeringSolutions ArchitectSpace & Mission SystemsStorage & BackupTelecom & Hybrid ReliabilityWindows Systems Administration
Ad Tech and RankingAdministrative Compliance AnalyticsAds & Personalization MLAgentic AI WorkflowsAI Agents and SafetyAI Automation AnalyticsAI Language TrainingAI Strategy and ArchitectureAnalytics EngineeringApplied GenAI ConsultingAutonomous Driving MLAWS Databricks EngineeringAzure Data EngineeringBI Analytics EngineeringBI Visualization EngineeringBiological Discovery ResearchBiostatistics and SafetyClinical Data EngineeringClinical Laboratory ScienceComputational GenomicsComputer Vision EngineeringComputer Vision LocalizationConsulting Data ScienceConversational AI EngineeringCredit and Fraud RiskCrypto and AI ResilienceData EngineerData EngineerData EngineerData EngineerData Engineering LeadershipData Governance ComplianceData Governance EngineeringData Infrastructure AnalyticsData Science InternshipsData Strategy LeadershipDatabase AdministrationDecision Science AIDigital Marketing AnalyticsE-commerce Data EngineeringEdge AI HardwareEnterprise Data ArchitectureEntry Level InternshipsEnvironmental and GeoscienceFinancial Data EngineeringFinancial Strategy AnalyticsFood Science ResearchForward Deployed AIFraud Risk AnalyticsGCP Data EngineeringGeneral Data PlatformGenerative AI EngineeringGenerative AI SystemsGeospatial GIS AnalyticsGovernment AI SecurityHealthcare Data ScienceHealthcare Risk AnalyticsHEOR and Clinical AIHPC ML EngineeringHR Data IntegrationHR People AnalyticsInformatica Data EngineeringInsurance Actuarial AnalyticsInsurance and ActuarialIT Operations AnalyticsJava Python Data EngKnowledge Graph EngineeringLaboratory Quality AnalyticsLife Sciences AILLM Core EngineeringLLM Evaluation & AgentsLogistics Operations AnalyticsManufacturing Data SystemsManufacturing Process AnalyticsMarket Economics ResearchMarketing ExperimentationMicrosoft Fabric DataMLOps EngineeringPalantir Foundry EngineeringPharma Analytical ChemistryPharma Process DevelopmentPhysical AI DataProcurement Sourcing AnalyticsPublic Health ResearchQuantitative Finance ResearchQuantum and ImageryRisk & Fraud MLRobotics and PerceptionRobotics ML EngineeringSAP BW DataSAP Master DataSearch & Recommendation MLSecurity and ClearanceSnowflake Data EngineeringSnowflake DBT EngineeringSpeech AI EngineeringSupply Chain ForecastingSupply Chain Planning
AI Product SecurityApplication Security EngineeringCloud Infrastructure SecurityCloud Security AssessmentDetection EngineeringEmbedded Firmware SecurityEnterprise Application SecurityFacility Security ManagementGeneral Cyber DefenseGovernance Risk ComplianceIdentity & Access ManagementNetwork Firewall EngineeringOffensive Security TestingOT Industrial SecurityPhysical Guard ServicesPhysical Security EngineeringPrivacy and AI GovernanceSecurity Architecture LeadershipSecurity Program ManagementSecurity Solutions SalesSOC OperationsThreat Intelligence AnalysisVulnerability ManagementVulnerability Research
Academic Product EngineeringAdobe Experience PlatformAgile Scrum MasteryAI Agent EnablementAI Content CreationArchitectural & Interior DesignAutonomous Vehicle ProductsBanking Product DesignBroadcast Production ManagementBusiness Systems AnalysisContact Center TechnologyConversation UX DesignCreative Agency DesignCybersecurity Product ManagementData & ML ProductsDefense Systems ManagementDeveloper Tools ProductDigital Health PlatformsE-commerce MerchandisingEngineering CAD DesignEnterprise Solution ArchitectureEvent & Studio TechFrontend Engineering ManagementGame & Level DesignGaming Product ManagementGenerative AI SolutionsGovernment SaaS ProductsHealthcare AI StrategyHRIS Product ManagementIndustrial Product DesignInfrastructure & ObservabilityInstructional Design & LMSInsurance Claims TechnologyInsurance Product ManagementIT Project ManagementITSM & CRM ArchitectureLegal Tech ProductsNPI Program ManagementPLM Solution ArchitectureProduct AnalyticsProduct ManagementProduct ManagementProduct ManagementProduct ManagementProduct ManagementProduct ManagementProduct ManagementProduct ManagementProduct ManagementProduct ManagementProduct ManagementProduct ManagerSalesforce Product OwnershipSAP ERP SolutionsSemiconductor Product EngineeringSmart Manufacturing AISupply Chain Product ManagemenTechnical Program ManagementUI/UX Design SystemsUX Research
Aerospace Manufacturing QAAerospace Systems EngineeringAerospace Systems TestAnalog IC DesignASIC Physical DesignASIC Verification EngineeringAutomotive Repair TechnicianAutomotive Systems EngineeringAutonomous Vehicle QACivil Structural EngineeringCNC Machining & FabricationConstruction Project ManagementElectrical Inspection & SafetyElectronics Test EngineeringEmbedded Firmware EngineeringEnvironmental Health & SafetyFacilities Maintenance EngineeringField Service EngineeringHVAC Design EngineeringIndustrial Automation ControlsIndustrial Construction QAIndustrial Maintenance EngineeringLandscaping & Yard OpsManufacturing Process EngineeringMaterials & Chemical LabMechanical Product DesignNetwork Hardware QAPCBA Test EngineeringPharmaceutical Manufacturing EngineeringPhotonics Test EngineeringPower Electronics DesignPower Systems EngineeringProduction OperationsRF & Avionics DesignSemiconductor Process EngineeringSilicon ValidationSpacecraft Mechanical EngineeringSubstation Automation QA
Account-Based Demand GenAI Product MarketingApparel Retail ManagementBanking Relationship SalesContent Communications MarketingEnterprise AI SalesEnterprise Customer SuccessEnterprise Security SalesExperiential Sports MarketingFrontline Service SalesGeneral Business DevelopmentHealthcare Brand MarketingHigh-Incentive Sales RepsIndustrial Technical SalesIndustrial Territory SalesInsurance Lines SalesMarketing Analytics OperationsPartner Channel StrategyPayments Business DevelopmentPerformance Paid MediaPharmaceutical Clinical SalesProcurement Supply ChainRetail Trade MarketingSales Compensation OperationsSales Development RepsSEO Digital MarketingSocial Creative DesignTechnical Solutions Engineering
Automotive OperationsBanking Operations & LendingCommodity & Indirect SourcingCompliance & Contact QACompliance ManagementConstruction & Electrical ProjectsContinuous Improvement & LeanCulinary & Kitchen StaffCustodial & Building ServicesCustomer ServiceDelivery & Traffic CoordinationEducational & Correctional ProgramsEHS Compliance & SafetyEngineering Executive LeadershipEnvironmental Permitting & CarbonERP & WMS SystemsEvent Production & ConcertsExecutive & GTM RecruiterExecutive & Legal AdministrationFacilities Management & OperationsFood Safety QAGeneralist & Early Talent RecruiterGrocery Produce & DeliHealthcare OperationsHealthcare Staffing RecruiterHospitality Concessions & BarHR Business PartneringHR Operations & PayrollIT & Program ProcurementLast Mile LogisticsMaintenance Planning & ReliabilityMajor Construction Project ControlsMaterials & Inventory ControlMission & Defense OperationsOperations & TrainingOperations ManagementOperations ManagementOrganizational Change ManagementPlant & Operations LeadershipProduction Planning & SchedulingProduction SupervisionProject Coordination & AdminPublic Sector Project ManagementReal Estate & Land DevelopmentRestaurant General ManagementRetail Softgoods OperationsRobotics Deployment ProjectsSemiconductor & IE OperationsSpanish Market QAStudent Life & FraternitySupplier QualitySupply Chain StrategyTechnical & Manufacturing RecruiterTextile & Garment QCWarehouse & Distribution OperationsWarehouse Material Handling
Accounts PayableActuarial PricingBusiness AnalyticsCommercial FinanceCorporate DevelopmentCorporate Governance ComplianceCorporate TaxCost AccountingCredit RiskERP SystemsFinance AI InnovationFinancial Crime ComplianceFinancial ReportingFP&A AnalysisFrench Financial QAFund AccountingHealthcare RevenueInternal AuditPayments EngineeringPayroll AdministrationProject ControlsPublic AccountingQuality AuditingQuantitative TradingReal Estate FinanceRetail BankingSAP FinanceSurety UnderwritingThird-Party RiskTreasury OperationsWealth Advisory
Acute Care NursesBehavioral HealthCardiac Imaging TechsCardiology PhysiciansClinical DataClinical DevelopmentClinical EngineeringClinical InformaticsClinical LaboratoryClinical PharmacyClinical Project MgmtClinical Research AssociatesClinical SpecialistsComputer System ValidationDentistryDietary ServicesEmergency MedicineHealthcare RecruitingHospitalistsInfection ControlLab QC OperationsLaboratory ManagementLaboratory Quality ControlLong-Term CareMedical AssistantsMedical CodingMedical Device QAMedical Device TechsMedical EducationMedical Science LiaisonsMedical WritingNurse Case ManagersNursing AdministrationOccupational HealthOncologyPediatricsPharma Manufacturing QAPharmacovigilancePrimary CarePrivate MedicalPsychiatry PhysiciansQuality and ValidationRadiology PhysiciansRadiology TechnologistsRegulatory AffairsRehabilitation TherapistsResearch CoordinatorsRespiratory TherapistsRetail PharmacySurgerySurgical TechsTelehealth ProvidersVeterinary Medicine
Biomedical and Civil EngineeringBioprocess & AnalyticalComputational Biology and GenomicsCore Facility ResearchCorporate AI ResearchEnergy Systems & AIFaculty Administration and MedicineGeneral Academic ResearchGeneral Postdoctoral ResearchHealth Behavior StudiesMaterials and Quantum ScienceNeuroscience & PsychologyNeuroscience and NeurologyPharmacometrics & RegulatoryPhysics and Energy ResearchPolytechnic Engineering InstructionQuantum & AcceleratorRobotics & AITenure-Track FacultyTraditional Campus Instruction
← Select a job to preview