Regulatory Affairs
414 open positions
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Senior Product Engineer StrykerDenver, Colorado $86k–$86k1mo Lead sustaining engineering efforts to drive design changes for existing Sports Medicine commercial products, focusing on performance, safety, compliance, and supply continuity.
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Chief Technology Officer↗ Trendlines Medical Singapore Pte. Ltd.Clementi, S00, SG 1mo Provide critical technical and engineering oversight to a portfolio of early-stage medical device companies, defining strategy for hardware and software product development.
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Principal Systems Engineer - Medical Devices ZollUS CA San Jose $144k–$144k1mo Lead system-level architecture, design, and verification for complex defibrillator and patient monitor systems used in critical care.
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Senior Regulatory Affairs Specialist University-Health-NetworkMississauga, ON, ca $85k–$85k1mo Prepare technical documents for regulatory submissions, maintain regulatory files and licenses across EU, US, and Canada, and manage post-market surveillance for medical devices.
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Laboratory Project Specialist NemeraChicago, Illinois, us $85k–$85k1mo Lead planning, development, and execution of verification activities for medical device products, serving as a technical expert in device testing and design control.
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Sr. Director, RAQA - Japan IntuitiveTokyo, jp 1mo Leading Regulatory Affairs, Quality Assurance, and Safety Control for the Japanese medical device market, ensuring compliance with PMDA/MHLW regulations and maintaining product safety standards.
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Business Development Manager - Medical Services SgsRemote $65k–$65k1mo Drive profitable growth for SGS UK's Medical Device Certification portfolio by identifying and securing high-value business opportunities with new, existing, and dormant customers.
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Lead System Designer - CT GehcIND19-01-Bengaluru-EPIP 122 (Phase II) 1mo Lead system design and development for Hybrid CT imaging devices, ensuring design outcomes meet quality, regulatory, and performance requirements.
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Technical Associate↗ BiocompositesKeele, ENG, GB 1mo Provide scientific support for R&D and regulatory teams, ensuring pre-clinical testing compliance and supporting regulatory submissions for medical device products.
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Director External Manufacturing↗ Kindeva Drug DeliveryLoughborough, ENG, GB 1mo Strategy, oversight, and performance management of outsourced manufacturing activities for medical device products, ensuring compliance, cost-effectiveness, and supply resilience.
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Sr Manager Regulatory Affairs- LATAM DexcomRemote Florida $149k–$149k1mo Develop and champion regulatory strategy for Dexcom's CGM products in Latin America, ensuring compliance with regional requirements and supporting international growth.
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Packaging Engineer 3↗ Fresenius Medical CareReynosa, Tamaulipas, Mexico 1mo Design, develop, and qualify packaging systems for sterile and non-sterile medical devices to ensure product integrity, sterility, and regulatory compliance.
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Lead Regulatory Affairs Specialist (m/f/d) NovantaBerlin, Germany 1mo Ensures medical devices meet regulatory requirements and manages timely submissions/approvals for market placement.
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Specialist, Commercial QA DanaherTokyo, Japan $0k–$0k1mo Serve as the Safety Management Officer for medical devices and IVD products in Japan, ensuring compliance with PMD Act and GVP requirements while managing post-market safety and quality.
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R&D Engineer ConvaTecDeeside, Wales, GB 1mo Design, develop, and manage the lifecycle of Infusion Care medical devices, ensuring compliance with regulatory standards and design control processes.
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Regulatory Affairs Specialist II (IVD/Medical Devices)↗ Thermo Fisher ScientificSão Paulo, SP, BR 1mo Ensure product compliance and market access for innovative diagnostic solutions (IVD/Medical Devices) by managing regulatory submissions and maintaining product registrations.
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Senior Director, Technical Development Lead, Device↗ Bluerock TherapeuticsToronto, Ontario, Canada $230k–$230k1mo 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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Development Engineer - Medical Device↗ Nuwellis, Inc.Eden Prairie, MN, US $105k–$125k1mo Design, prototype, and evaluate electro-mechanical medical devices and disposable products throughout the product lifecycle.
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Senior Technical Writer - iSens - Porto↗ AbbottPorto, P13, PT 1mo Creating clear, concise, and accurate technical documentation (requirements, specifications, V&V protocols, user guides, API references) for healthcare products to support developers, customers, and internal teams.
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Associate Director, Drug/Device Combination Products - Method Development & Testing↗ MerckRahway, NJ, US $142k–$142k1mo Leading a Center of Excellence to develop and validate functional test methods for drug/device combination products, supporting development, stability, and design verification.
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Senior Design Lead↗ HCLTechBrooks, KY, US $78k–$148k1mo Lead end-to-end eIFU (electronic Instructions for Use) and labeling remediation projects from initiation through commercial release for BD product portfolios.
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Senior Regulatory Affairs Specialist↗ Siemens HealthineersRemote $83k–$83k1mo Prepare, submit, and maintain regulatory submissions and lifecycle documentation for medical devices, serving as a subject matter expert for design control and new product development.
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Regulatory Affairs Manager ZeissgroupBangalore 1mo Execute regulatory strategies and manage end-to-end submissions for ophthalmic devices, lenses, eye drops, cosmetics, and dietary supplements across APAC markets, ensuring alignment with global standards.
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Regulatory Affairs Program Manager (m/f/d) Digital Health↗ Olympus CorporationRemote 1mo Coordinate and manage regulatory activities for the Smart Connected Care (SCC) Unit, establishing strategies for digital health solutions including AI and Software as a Medical Device (SaMD) to ensure global compliance.
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Safety Engineer ElektaCrawley 1mo Ensure medical devices are safe, effective, and secure throughout their lifecycle by leading risk management activities and driving process improvements.
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Sustaining Engineer I↗ Origen BiomedicalAustin, TX, US 1mo Support on-market Class I and Class II sterile medical devices through technical support, process improvement, and risk mitigation.
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Sr. Systems Engineer AbbVieNorth Chicago, IL, us 1mo Lead systems engineering for drug/device combination products, integrating multiple disciplines to ensure robust patient-centric design and performance.
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Mechanical Engineer-Hybrid↗ Elyon InternationalNew Kensington, PA, US 1mo Designing and validating medical device components and systems, ensuring regulatory compliance and optimizing product performance.
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Clinical & Regulatory Internship, Summer 2027 EdwardsUSA IRV-1442 Alton/MIC $54k–$54k1mo Summer internship for early-career students to gain hands-on experience in clinical or regulatory affairs within the medical device industry.
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Senior Verification Engineer↗ Leica MicrosystemsBoon Lay, S00, SG 1mo Design verification methodology, plans, and procedures for new medical microscopy products to ensure quality, reliability, and regulatory compliance.
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Senior Manager, Global Device Quality ViatrisNorthern Cross, Dublin, Ireland 1mo Provide global leadership to establish, maintain, and implement Viatris' Global Quality Standards for medical devices and combination products, ensuring compliance with international regulatory requirements.
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Product Development Engineer EnvistaUnited States of America, California, Thousand Oaks $99k–$99k1mo Execute New Product Development for surgical implants, prosthetics, and instruments through concept, design, verification, and transfer to production.
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Engineer III, Device Development↗ Alexion PharmaceuticalsBoston, MA, US $102k–$102k1mo Engineer III supporting human factors engineering and usability engineering for medical device and combination product design, development, and lifecycle management.
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Sr Project Engineer, Development GlobusmedicalAudubon, PA 1mo Lead end-to-end engineering for medical device product lines from concept through FDA approval and manufacturing.
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Sr. R&D Manager BaxterBellevue, Washington $152k–$152k1mo Lead Electrical, Firmware, and Mechanical Engineering teams to deliver compliant medical devices and drive new product development.
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Sustaining Engineering Manager CadwellCompany Headquarters $140k–$140k1mo 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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Post Market Surveillance Manager (Medical Devices) OwensminorRemote $100k–$100k2mo Establishing and managing a global Post Market Surveillance (PMS) and Quality Assurance Regulatory Affairs Compliance (QARAC) audit program for medical devices to ensure regulatory compliance and quality system effectiveness.
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Regulatory Affairs & Quality Assurance Specialist (m/f/d)↗ DeepspinBerlin, BE, DE $70k–$80k2mo Support medical device certification for a flatbed MRI system in the US and Europe while maintaining the Quality Management System.
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Device Engineer III GileadUnited States - California - Foster City $118k–$118k2mo Support commercialization and sustaining engineering for drug-device combination products from design transfer through ongoing commercial support.
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Medical Device und Pharmacovigilance Manager SobiMunich, BY, de 2mo Establishing and maintaining the company's pharmacovigilance system while ensuring compliance with medical device regulations, serving as the interface between pharmaceutical and medical device regulatory frameworks.
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RA Manager - Regulatory Devices (d/f/m), Kundl, Austria↗ SandozKundl, T, AT $67k–$67k2mo Deliver global compliance and regulatory approval for medical devices and drug-device combination products, serving Health Authorities and Notified Bodies.
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Release Manager (w/m/d) MesalvoRemote 2mo Plan, coordinate, and execute software releases, service packs, and hotfixes for medical software solutions in regulated environments.
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