Regulatory Affairs
749 open positions
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Senior Data Standards Analyst BostonscientificMarlborough US-MA, United States | US-MN-Arden Hills 3mo Establishing, maintaining, and governing enterprise data standards to support the development, manufacturing, regulatory compliance, and commercialization of medical devices.
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Lead, Global Complaint Management↗ Icu MedicalChennai, Tamil Nadu, India 3mo Lead global complaint management operations for medical devices, supervising analysts to handle customer complaints, escalate complex events, and ensure regulatory compliance.
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Medical Device Auditor ISO13485(home based)↗ Bsi 3mo Assess ISO13485 quality management systems and associated medical device regulatory requirements on customer sites or remotely, write comprehensive reports, and present findings to clients.
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Senior Regulatory Affairs Specialist IntuitiveSunnyvale, CA, us 3mo Develop regulatory plans, review design documentation, and prepare submissions for medical device approvals in the US, Canada, and EU.
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Senior Regulatory Affairs Engineer ElektaVeenendaal 3mo Enable global market access for medical devices by ensuring regulatory approvals, compliance, and successful product introduction across international markets.
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Standortleitung AEMP (m/w/d) am Standort Bad Tölz Asklepios Service Reinigung GmbH Alsbach-HähnleinBad Tölz, BAYERN 3mo Leading the Medical Device Reprocessing (AEMP) site in Bad Tölz, ensuring safe, compliant, and efficient reprocessing of medical devices.
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Fachexperte für Heil- und Hilfsmittel und Digitale Gesundheitsleistungen (m/w/d) AOK Sachsen-AnhaltMagdeburg, SACHSEN_ANHALT 3mo Ensure subject matter expertise in medical devices, aids, and digital health services; evaluate legal/regulatory changes and derive process measures for AOK Sachsen-Anhalt; develop innovative concepts and cost-controlling measures.
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Strategist, Regulatory Affairs ClinChoiceCincinnati 3mo Manage, plan, prepare, and deliver electronic and paper-based regulatory documentation to support global medical device product registrations, renewals, and customs tenders.
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Principal Systems Engineer - Medical Devices ZollUS CA San Jose $144k3mo Lead system-level architecture, design, and verification for complex defibrillator and patient monitor systems.
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Technical Study Manager (m/w/d) / Manager Technische Studien (m/w/d) NAMSA Laboratory Services GmbHRemote 3mo Lead scientific planning, execution, and reporting of regulatory Extractables & Leachables (E&L) and chemical characterization studies for medical devices per ISO 10993-18.
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Program Manager, CQR↗ Vb SpineRemote $145k–$155k3mo Lead medium-complexity Clinical Quality & Regulatory (CQR) programs to ensure successful delivery from initiation through completion, aligning with organizational goals and PMOs.
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Sr Manager Regulatory Affairs- LATAM DexcomRemote $149k–$248k3mo Develop and champion Dexcom's regulatory strategy in Latin America, ensuring compliance for CGM products and supporting international growth.
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Senior Director, Technical Development Lead, Device↗ Bluerock TherapeuticsToronto, Ontario, Canada $230k3mo Provide strategic and technical leadership for the development and execution of delivery device systems supporting the company's combination cell therapy portfolio.
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Design Assurance Engineer / Medical Devices (m/f/d) NovantaBerlin, Germany 3mo Design Assurance Engineer responsible for creating quality plans, reviewing design verification/validation specifications, and leading risk management for medical devices.
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Director, Project Leadership - Compliance PM & ALD AbbottUnited States - California - Alameda $172k3mo Lead the global Compliance PM & ALD portfolio, overseeing CAPA, regulatory compliance, labeling changes, and UDI initiatives for medical devices.
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Sr. Systems Engineer AbbVieNorth Chicago, IL, us 3mo Lead systems engineering for drug/device combination products, integrating multiple disciplines to ensure robust patient-centric design and performance.
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Senior Manager, Global Device Quality ViatrisNorthern Cross, Dublin, Ireland 3mo Provide global leadership to establish, maintain, and implement Viatris' Global Quality Standards for medical devices and combination products, ensuring compliance with global regulatory requirements.
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Sr Project Engineer, Development GlobusmedicalAudubon, PA 3mo Lead end-to-end engineering for medical device product lines from concept through FDA approval and manufacturing.
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Manager Special Operations (SpOS) Europe (w/m/d) TÜV SÜD AGHamburg, HAMBURG 3mo Leading the Special Operations (SpOS) team across Europe, implementing processes and interfaces for non-standardized projects, and coordinating strategic new customer onboarding.
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Sustaining Engineering Manager CadwellCompany Headquarters $140k3mo Leads the Engineering Lab team in developing, maintaining, and improving Cadwell's medical devices, covering failure analysis, design verification, and post-release sustaining.
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Regulatory Program Manager AppleShanghai, China 3mo Manage regulatory submissions, product launches, and policy interactions for Apple's medical device portfolio across China and APAC.
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Release Manager (w/m/d) MesalvoRemote 3mo Plan, coordinate, and execute software releases, service packs, and hotfixes for medical software solutions while ensuring compliance with regulatory standards.
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Manager of Regulatory Operational Compliance IdexxWestbrook, ME $105k3mo Lead a team responsible for preparing global product documentation for veterinary and water diagnostic products to support regulatory submissions.
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Head of RA GaldermaTokyo 3mo Lead regulatory strategy, operations, and compliance for Galderma's Japan market, serving as the Marketing Authorization Holder General Manager (Sokatsu) for medical devices and skincare.
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Engineer IV/Complaint Analysts TakedaLexington, MA $104k–$163k3mo Engineer IV leading engineering operations for medical devices, managing complaint investigations, and supporting design verification and risk management.
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Regulatory Affairs Leader - ARC GehcWuXi, CN 3mo Provides strategic regulatory leadership for ARC regulatory programs, including global RA support for registration planning, submissions, notified body and quality system audits, and program implementation.
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Senior Project Manager (m/w/d) 3C-Carbon Composite Company GmbHLandsberg am Lech, BAYERN 3mo Leading product development projects for high-tech carbon fiber composite structures in the medical device industry, ensuring compliance with regulatory standards.
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Entwicklungstechniker/in Leonhard Lang GmbHAmras, TIROL €41k3mo Development of medical devices from concept through prototyping to series production and handover, including verification, validation, risk analysis, and lifecycle support.
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Senior Director, Device Platform Engineering HelloheartRemote US $220k3mo Lead the end-to-end lifecycle of device product lanes, serving as the technical systems owner for hardware, firmware, manufacturing, and field performance to build a cardiac prevention platform.
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Clinical Development Scientist, Ultrasound &EI PhilipsShanghai 3mo Executes evidence-generation processes, clinical development, and market access strategies for New Product Introduction (NPI) projects and post-market activities in the medical device sector.
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Regulatory Affairs Specialist MedlineRemote, US $79k–$119k4mo Plan and execute global regulatory activities to obtain and maintain regulatory approvals for medical devices across new launch markets and post-market changes.
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Regulatory Lead - Medical Device Software RaySearch Laboratories AB (publ)Stockholm, Sweden 4mo Own global regulatory strategy and lifecycle oversight for medical device software products, ensuring compliance and driving market access.
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Director, Regulatory Affairs (f/m/d) ClarioclinicalEstenfeld, Germany 4mo Lead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485, and international medical device regulations, acting as Person Responsible for Regulatory Compliance (PRRC).
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Risk Management (Medical Devices) AltentechnologyusaTroy, MI 4mo Conduct technical reviews and development of risk management deliverables (PHA, BE CT CHA, RMP, FMEA) for medical device programs, ensuring alignment with systems engineering and regulatory standards.
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Vice President, Regulatory & Quality AdaptivebiotechnologiesRemote (WFH) $261k4mo Develop and lead global regulatory strategy and quality oversight for diagnostic products to ensure compliance and support commercialization.
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