Regulatory Affairs
735 open positions
-
Product Development Team Lead↗ InertiaToronto, Ontario, Canada 6d Lead medical device projects from concept to manufacturing launch, acting as a primary client contact and fractional CTO for startups and scaleups.
-
RA Analyst↗ Werfen 6d Execute regulatory strategies for In Vitro Diagnostic (IVD) and medical devices commercialized in Colombia and LATAM distribution countries, ensuring compliance, product registration, and lifecycle management.
-
Interventional Cardiologist↗ Tunnell Government Services, Inc.Remote 6d Provide expert consulting services to the FDA CDRH to support regulatory reviews of cardiovascular medical devices.
-
Facharzt/-ärztin für die klinische Bewertung von Medizinprodukten (w/m/d)↗ TÜV Rheinland GroupCologne, North Rhine-Westphalia, Germany 6d Evaluate clinical aspects of manufacturer documentation, review clinical trial results, and assess clinical evaluations of medical devices.
-
Senior Staff Medical Writer (Remote) StrykerRemote $110k–$238k6d Lead clinical evidence strategies and scientific documentation to support regulatory submissions, market access, and product lifecycle decisions for medical devices.
-
-
Sr. Engineer, Product Sustaining - Wayne, NJ↗ GetingeWayne, NJ, US $117k–$125k6d Technical leadership and engineering support for sustaining activities including product improvements, design changes, cost reduction, component obsolescence management, manufacturing support, and complaint investigations for released medical devices.
-
Analyst, Information Technology BaxterBangalore, Karnataka, IN 6d Identify, design, and deliver technology solutions that optimize business processes in Medical, Quality, Regulatory, and Supply Chain functions within a medical device organization.
-
Global Head of Technical Regulatory & Quality (CMC, Quality & MDD) IconRemote 6d Provides global oversight and leadership for Chemistry, Manufacturing and Control (CMC), Quality, and Medical Device & Diagnostic (MDD) consulting services, including strategic planning for global dossiers, QA unit support, and quality system development.
-
Sr Dir Regulatory Intelligence & FDA Engagement MedlineRemote, US $203k–$305k6d Establishing and leading a global regulatory intelligence capability to proactively identify, assess, and drive implementation of regulatory requirements and emerging trends for Medical Devices, Pharmaceuticals, Cosmetics, and Combination Products.
-
-
-
Principal Engineer, Supplier Development EdwardsUSA - California – Irvine $121k–$171k6d Lead end-to-end technical validation of suppliers and drive design/development of complex interventional catheter delivery systems for implantable cardiac devices.
-
Engineer and Regulatory Specialist↗ Applied Technical Services LLCColorado Springs, CO, US 6d Prepare, review, and submit technical documentation for FDA regulatory submissions and provide regulatory consulting to clients in manufacturing, aerospace, medical, and defense sectors.
-
Senior Human Factors Engineer IntuitiveSunnyvale, CA, us 6d Lead usability engineering and human factors validation for complex, software-controlled electro-mechanical medical devices to ensure safety and ease of use.
-
Senior Scientist, I: Biocompatibility AbbVieBranchburg, NJ, us 6d Subject Matter Expert supporting biocompatibility evaluation requests for marketed medical devices, leading change control activities, and ensuring regulatory compliance.
-
Regulatory Affairs Manager-Medical Devices JobgetherRemote $120k–$140k7d Lead global regulatory strategies and ensure compliance across the full lifecycle of medical devices, supporting product development, commercialization, and market access.
-
-
Senior Risk Management Specialist↗ Oticon MedicalGothenburg, Västra Götaland County, Sweden 7d Lead and continuously improve the risk management framework for advanced bone-anchored hearing systems, ensuring product safety, effectiveness, and compliance across the entire product lifecycle.
-
Senior Regulatory Affairs Specialist BostonscientificAmerican Free Zone, San Francisco de Heredia, Costa Rica | N/A 7d Senior Regulatory Affairs Specialist supporting product and manufacturing changes, regulatory submissions, and compliance for the Interventional Therapies Division.
-
Product Development Engineering Manager↗ Xeridiem Medical DevicesTucson, AZ, US 7d Leads the Product Development Engineering team to oversee New Product Development projects through the Stage Gate process, ensuring successful commercialization of medical devices.
-
Product Engineer↗ Thompson Surgical InstrumentsTraverse City, MI, US 7d Define, analyze, and implement system and part requirements for medical device products from concept to commercialization, ensuring they meet user needs, validation, and usability standards.
-
INTERNATIONAL R&D PROJECT – (PARIS & BARCELONA)↗ iVascular 7d Design, develop, and validate medical-grade metal tubing processing routes and characterize metallic materials to support the industrialization of medical devices.
-
Technical Specialist MedTech | Clinical Evaluation & Technical Documentation↗ Mdx CroRemote 7d Prepare Clinical Evaluation Plans (CEPs) and Reports (CERs), develop clinical evaluation strategies, and prepare medical device technical documentation under EU MDR and FDA 510(k) requirements.
-
Regulatory Affairs Medical Devices↗ FerrerBarcelona, Catalonia, Spain 7d Global regulatory affairs specialist responsible for preparing, maintaining, and submitting regulatory documentation for Ferrer's medical device products and cross-functional projects.
-
Analista de assuntos regulatórios↗ LoccusCotia, São Paulo, Brazil 7d Senior Regulatory Affairs Analyst ensuring compliance and product registration for medical devices in Brazil.
-
Medical Device Manager↗ Curaleaf InternationalLondon, England, UK 7d Lead the day-to-day management of a global medical device portfolio, overseeing new market registrations and ensuring compliance with regulatory frameworks.
-
Quality Auditor↗ Cure TalentRemote 7d Conducting Stage 1 and Stage 2 Quality Management System audits for medical device manufacturers against ISO 13485 and EU MDR regulations.
-
Post Market Surveillance Specialist↗ PhilipsBengaluru, Karnataka, India 7d Ensures standard Post Market Surveillance (PMS) and Risk Management (RM) processes, plans, and reports across business units; monitors safety signals and assesses product relationships to complaints.
-
Senior Specialist, Quality Assurance and Regulatory Compliance↗ Leica BiosystemsNewcastle upon Tyne, ENG, GB 7d Leading and coordinating global field action management (recalls, FSCAs, corrections) for medical devices and IVDs to ensure regulatory compliance and inspection readiness.
-
Vice President Research And Development↗ OcclutechHelsingborg, Skåne County, Sweden 7d Lead product-focused research and development for medical devices, guiding products from concept through validation, launch, and serial production while ensuring robust design control and risk management.
-
Principal Scientist, CMC Regulatory Affairs – Medical Devices & Combination Products OrganonUSA - Pennsylvania - Plymouth Meeting 7d Strategic leadership for global CMC regulatory programs supporting medical devices, drug-device combination products, and associated regulatory pathways from development through lifecycle management.
-
Vascular Surgeon↗ Tunnell Government ServicesRemote 7d Provide expert consulting services to the FDA CDRH to support regulatory reviews and approvals of cardiovascular medical devices.
-
-
Senior Regulatory Affairs Manager GsknchChina - Shanghai - HuangPu District - The Headquarters Building 7d Lead Regulatory Affairs activities for defined product portfolios in China, enabling business growth while protecting product compliance throughout the lifecycle for medicines, medical devices, cosmetics, and foods.
-
Senior Systems Engineer AbbottUnited States - California - Alameda $114k–$228k7d Lead design and development of cloud and mobile platforms for a biosensing medical device (Lingo) to track biomarkers like glucose and ketones.
-
-
-
Quality System Specialist- Labeling MarmonCharlottesville, VA, US 7d Manages the development, maintenance, and controlled implementation of medical device product and packaging labeling to ensure regulatory compliance and support new product development.
-
Senior Reliability Engineer MedtronicMounds View, Minnesota, United States of America $107k–$161k7d Analyze product performance data, support risk assessments, and investigate quality issues to improve reliability of implantable medical devices like pacemakers and defibrillators.
-
-
Senior Director, Corporate Preclinical Development and Toxicology BdxUSA NC - Durham - Davis Drive 7d Provide strategic, scientific, and operational leadership for corporate preclinical development and toxicology, ensuring safety and compliance for medical devices and combination products.
-
Senior Manager, Regulatory Affairs DanaherVista, California, United States $155k–$165k7d Develop and execute global regulatory strategies for high-complexity hardware and software products (IVDs, digital pathology) to enable commercialization in clinical oncology.
-
Regulatory Compliance Engineer RebuildmanufacturingRe:Build Tekna 7d Ensure product safety, efficacy, reliability, and compliance with regulatory requirements for New Product Development projects.
-
Software Technical Program Manager (SW TPM) - MedTech AltentechnologyusaWestminster, CO $125k–$145k7d Coordinate software testing, verification, validation, and new product development lifecycles for medical devices, ensuring compliance with quality system requirements and regulatory standards.
-
-
-
Senior Entwicklungsingenieur Konstruktion (m/w/d) DERU GmbHRemote 8d Senior development engineer responsible for the full product development lifecycle of complex medical implants and instruments, ensuring compliance with regulated standards.
-
Associate - Regulatory Affairs ClinChoiceIndia 8d Manage and maintain regulatory data within the EMA Article 57 (A57) database, ensuring compliance with IDMP standards and supporting electronic submissions to the European Medicines Agency.
-
Associate Director, Regulatory Affairs - In Vitro Diagnostics and Digital Health RegeneronRemote $180k–$293k8d Lead regulatory strategies for Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology across development, submissions, and commercialization.
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