Regulatory Affairs
414 open positions
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R&D Manager↗ Vein360Blue Ash, OH, US 1mo Lead a team of engineers and project managers to restore used medical devices into market-ready solutions, managing the full product lifecycle from concept to regulatory submission.
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Project Manager, Covington, GA BdxUSA GA - Covington BMD 1mo Leading R&D projects and programs for the design, development, and FDA compliance of Class 1, 2, and 3 medical devices to ensure sustained production and successful commercialization.
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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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Senior Regulatory Affairs Specialist↗ OuraRemote, US $0k–$0k1mo Lead regulatory and quality strategy for product development, approval, and lifecycle management for wellness and regulated features in a Software as a Medical Device (SaMD) portfolio.
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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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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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Director, Global & International Regulatory Affairs #4810↗ GrailWashington, DC, US $169k–$169k1mo Define and lead global regulatory strategies for multiple therapeutic areas, product lines, or technology platforms to ensure compliance with international regulations and represent the company with regulatory agencies.
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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 QA PMS Clinical Analyst/Lead↗ Ebr Systems, Inc.Santa Clara, CA, US $115k–$115k1mo Senior clinical and technical subject matter expert ensuring regulatory compliance, identifying safety signals, and supporting product quality and patient safety for implantable medical devices.
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Core Diagnostics Regulatory Affairs Managers↗ AbbottPorto, P13, PT 1mo Primary Regulatory Affairs representative for a manufacturing site, ensuring product commercialization and compliance with global regulations.
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Senior Systems Engineering Compliance Engineer↗ AccurayMadison, WI, US 1mo Lead regulatory compliance and safety for medical radiotherapy systems, ensuring alignment with global standards like IEC 60601 and managing submissions to notified bodies.
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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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Regulatory Operations Manager↗ Siemens HealthineersPalo Alto, CA, US $130k–$130k1mo Lead global regulatory operations to support market access, regulatory requirements, and operational effectiveness for Varian's medical device portfolio.
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Product Security Process Analyst II↗ TerumoLakewood, CO, US $124k–$124k1mo Interpreting regulatory and industry cybersecurity requirements for regulated medical devices and shaping their implementation, documentation, and sustainment.
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Assistant General Counsel, Privacy & Data Protection↗ Intuitive (intuitive Surgical)Freiburg, BW, DE 1mo Senior privacy counsel supporting EMEA operations for a medical device leader, ensuring compliance with GDPR and international data protection laws across product development and commercial activities.
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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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Human Factors Engineer I↗ ArthrexNaples, FL, US 1mo Lead Human Factors efforts for user interface test and development of medical devices throughout the product lifecycle.
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Manager, Compliance Engineering↗ Tandem Diabetes Care, Inc.San Diego, CA, US $142k–$142k1mo Lead compliance testing and certification for innovative medical devices, ensuring products meet safety, EMC, wireless, and regulatory requirements from development through commercialization.
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Senior R&D Engineer, Sports Medicine↗ Smith+nephewMansfield, MA, US $102k–$102k1mo Lead sustaining engineering and product support for medical devices used in shoulder, hip, and knee repair procedures.
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Senior Systems Engineer - Medical Devices (Electromechanical)↗ Systems AllySan Diego, CA, US 1mo Lead systems engineering for complex medical devices and electromechanical systems from concept through launch, ensuring safety, reliability, and regulatory compliance.
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Senior R&D Design Engineer (Medical Device | CREO) / East area↗ Recruitpedia Pte. Ltd.Singapore, S00, SG 1mo Lead the design and development of new medical products from concept through to production, ensuring compliance and manufacturability.
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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 Packaging Engineer↗ Boston ScientificArden Hills, MN, US $85k–$85k1mo Senior Packaging Engineer leading sustaining engineering activities, developing new packaging processes/materials, and resolving complex performance issues for medical devices.
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Compliance Engineer↗ Clarius Mobile HealthRemote 1mo Own hardware compliance and product safety certification for handheld medical ultrasound devices across electrical, mechanical, firmware, and software domains.
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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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Medical Devices Safety Officer↗ Central and North West London Nhs Foundation TrustLondon, ENG, GB 1mo Lead the Trust-wide medical device safety programme, ensuring compliance with MHRA requirements and managing the full lifecycle of medical devices to improve patient safety.
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Manager, Regulatory Affairs Strategy AlconFort Worth, Texas, US 1mo Lead regulatory strategy, compliance, and lifecycle management for Alcon's Dry Eye Ocular Health and Contact Lens Care portfolio.
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Senior Specialist, Commercial Regulatory Affairs↗ Beckman Coulter DiagnosticsDL, IN 1mo Prepare, submit, and manage Import license applications, renewals, and Post Approval change applications for medical devices/IVD, ensuring compliance with country-specific regulations in India, Sri Lanka, and other SWA countries.
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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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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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