Regulatory Affairs
408 open positions
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Senior Manager, Regulatory Affairs (MedTech) FreseniusglobalLake Zurich, IL, US $160k–$170k1mo Senior individual contributor responsible for regulatory decision-making and strategy for complex or high-risk MedTech products and regions.
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Sr. Director, Regulatory Affairs EikontherapeuticsJersey City, New Jersey $235k–$235k1mo Lead regulatory strategy and compliance for a biopharmaceutical company developing novel treatments using advanced microscopy technology.
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Senior Development Technologist SmithnephewUK - Hull GBU Office 1mo Lead technical investigations and project delivery for new product development in the medical device sector, ensuring compliance with regulatory standards and quality management systems.
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Senior Device Quality Engineer HeartflowincSan Francisco $160k–$160k1mo Lead end-to-end design control and quality assurance for AI/ML-enabled Software as a Medical Device (SaMD) within the Software Development Lifecycle (SDLC), ensuring compliance with global medical device regulations.
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Senior Systems Engineer (all genders) (full-time, regular) AbbVieLudwigshafen, RP, de 1mo Senior Systems Engineer leading system architecture, integration, and design controls for aesthetic filler devices and therapeutic combination products in clinical and commercial development.
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Manager QREM & Pharmacovigilance FreseniusmedicalcarePAK Lahore - Office 1mo Manage product-related regulatory and quality activities including registration submissions, renewals, change notifications, pharmacovigilance, regulatory audits, and adverse event reporting for medical devices and drugs in Pakistan.
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?Entwicklungsingenieur Bad Kissingen, BAYERN 1mo Develop, verify, and maintain active medical devices and device software across the entire product lifecycle for lung function and cardiopulmonary diagnostics.
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Spec RA GSO MedlineWuhan 武汉 1mo Review and document labeling for commodity, medical device, drug, and cosmetic products to ensure compliance with internal procedures and federal regulations.
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Senior Quality & Regulatory Compliance Manager - Medical and In Vitro Devices↗ Sener DiagnosticsRemote 1mo Senior manager responsible for regulatory affairs and quality compliance for medical and in vitro diagnostic devices, acting as Technical Responsible (TR) and Person Responsible for Regulatory Compliance (PRRC).
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Regulatory Affairs Administrator ElektaWarsaw 1mo Coordinate regulatory block and release activities for medical device products and spare parts to ensure compliance and timely availability.
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Product Performance Clinical Lead AbbottUnited States - Minnesota - Plymouth $78k–$78k1mo Lead clinical expertise and regulatory reporting for medical devices in electrophysiology, heart failure, and vascular product lines.
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Senior Microbiologist OutsetmedicalSan Jose - HQ $112k–$112k1mo Subject-matter expert for microbiological safety across the product lifecycle, developing strategies, leading testing, and ensuring compliance for medical devices.
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Director, Regulatory Affairs CMC, Combination Products and Device GileadUnited States - California - Foster City $210k–$210k1mo Setting and leading global CMC regulatory strategy for complex device and combination product portfolios to enable successful global registration and lifecycle management.
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Senior Manager Regulatory Affairs MyhrabcAPAC > Australia > North Sydney NSW 1mo Manage regulatory submissions, lifecycle maintenance, and licensing for pharmaceutical and medical device products in Australia and New Zealand.
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Global Regulatory Specialist↗ Tobii Dynavox®Stockholm, Stockholm County, Sweden 1mo Ensure medical devices and mounting systems meet global regulatory requirements and support market access.
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Senior Lead Auditor (Medical Devices) AppleCupertino, United States of America 1mo Lead and maintain a risk-based internal and supplier audit program to ensure regulatory compliance for regulated medical device features.
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Senior Regulatory Affairs Specialist IntuitiveSunnyvale, CA, us 1mo Develop regulatory plans, review design documentation, and prepare submissions for medical device approvals in the US, Canada, and EU.
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Strategist, Regulatory Affairs ClinChoiceCincinnati 1mo 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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Software QA Engineer 2 DexcomRemote - United States $79k–$79k1mo Ensure conformance to software development processes and safety/quality regulations (IEC 62304, ISO 13485, 21 CFR 820) for continuous glucose monitoring devices.
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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 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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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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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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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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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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Regulatory Affairs Manager ZeissgroupBangalore 2mo 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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Design Assurance Engineer / Medical Devices (m/f/d) NovantaBerlin, Germany 2mo Ensuring quality and compliance for medical device design through verification, validation, and risk management.
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Sr. R&D Manager BaxterBellevue, Washington $152k–$152k2mo Lead Electrical, Firmware, and Mechanical Engineering teams to deliver compliant medical devices and drive new product development.
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Senior Manager, Global Device Quality ViatrisNorthern Cross, Dublin, Ireland 2mo 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–$99k2mo Execute New Product Development for surgical implants, prosthetics, and instruments through concept, design, verification, and transfer to production.
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Clinical & Regulatory Internship, Summer 2027 EdwardsUSA IRV-1442 Alton/MIC $54k–$54k2mo 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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Sr Project Engineer, Development GlobusmedicalAudubon, PA 2mo Lead end-to-end engineering for medical device product lines from concept through FDA approval and manufacturing.
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Sustaining Engineering Manager CadwellCompany Headquarters $140k–$140k2mo 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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