Regulatory Affairs
407 open positions
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DX Head of Quality Management & Regulatory Affairs, EMEA (f/m/d)↗ Siemens HealthineersMadrid, MD, ES 25d Lead the Quality Management & Regulatory Affairs function across the EMEA region, ensuring compliance, product safety, and operational excellence for commercial operations and customer services in the medical device industry.
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?Director, Regulatory Affairs (f/m/d) Estenfeld, BAYERN 25d Lead global regulatory activities to ensure compliance with FDA 21 CFR 820, ISO 13485, and international medical device regulations for respiratory, imaging, and cardiac safety solutions.
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Engineering Project Manager↗ Cirtec MedicalBrooklyn Park, MN, US $90k–$90k25d Managing and coordinating the development and manufacturing transfer of complex components, sub-assemblies, and finished medical devices.
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Environmental Compliance Program Manager IntuitiveSunnyvale, CA, us 25d Manage environmental compliance programs and regulated substance databases to ensure product conformance with global regulations for a medical device manufacturer.
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Senior Clinical Development Scientist / Medical Safety Manager PhilipsBothell, Washington, United States $149k–$149k26d Support clinical evidence strategy and medical safety throughout the product lifecycle for oral healthcare devices by evaluating clinical and post-market data and identifying safety risks.
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Clinical Engineer↗ Providence Health CareVancouver, BC, CA $0k–$0k26d Regional Clinical Engineer leading biomedical engineering projects, risk management, and capital planning to ensure safe medical device use across hospitals.
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Summer 2027 Internship - RA/QA - Regulatory Affairs - Michigan StrykerPortage, Michigan $0k–$0k26d Regulatory Affairs intern supporting global regulatory strategy, compliance, and product registration for medical devices.
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Manager, Field Action Process DanaherSunnyvale, California, United States $130k–$130k26d Manage Cepheid's global Field Action process to ensure compliant execution of recalls, corrections, removals, and post-market actions for medical devices and diagnostics.
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Product Development LCM Specialist↗ Straumann GroupCuritiba, PR, BR 26d Maintaining, improving, and optimizing dental implant products throughout their commercial life cycle, ensuring compliance with regulatory standards.
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Label Change Coordinator ConvaTecMichalovce, Slovakia 26d Coordinate and execute market- and compliance-driven packaging and labeling changes, translating label requests into production-ready artwork for medical devices.
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Principal Scientist, Human Factors MsdUSA - New Jersey - Rahway $157k–$157k28d Lead a Human Factors team to manage human performance activities across the product lifecycle for combination products and medical devices, ensuring regulatory compliance and optimizing user experience.
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Mechanical Senior Engineer↗ Zimmer BiometMontréal, QC, CA 28d Senior mechanical engineer leading technical execution of product improvements, design changes, and manufacturing process optimization for existing medical devices.
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Principal Device Quality Engineer HeartflowincSan Francisco $190k–$190k28d Global subject matter expert for software quality and design excellence, bridging rapid Agile development with rigorous medical device regulations for AI/ML-enabled digital health solutions.
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Global Design Change Engineer GehcSeongnam 29d Lead engineering design change execution by driving impact assessments, stakeholder alignment, and resolution of complex cross-functional issues to ensure compliant implementation of product and design changes throughout the product lifecycle.
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Regulatory Affairs Specialist HalmaRemote 29d Provides customer support on regulatory issues, leads CE marking activities, develops 510K submissions, and supports global product registrations for medical devices.
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Senior Engineer II, Device Development BiibhrCambridge, MA $117k–$117k29d Design, development, and lifecycle management of patient-centric drug delivery devices and combination products.
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Senior R&D Engineer EnvistaGermany, North Rhine-Westphalia, Herzogenrath 29d Leads the design, development, verification, validation, and lifecycle management of medical devices, ensuring regulatory compliance and quality standards.
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Sr Manager, Regulatory Operations - Publishing & Registration Management (Devices) AlconFort Worth, Texas, US $152k–$197k29d Direct product/process submissions and manage global strategies to ensure medical device compliance and timely approvals.
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VP, Neurology Regulatory Affairs IqviaWashington, DC, United States of America $160k–$160k1mo Lead regulatory strategy and submissions for neurology medical device clients, managing the full lifecycle from pre-clinical testing to commercialization.
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[쿠팡] 리테일 의료기기 및 공산품 컴플라이언스 담당자 CoupangSeoul 1mo Managing medical device compliance and product safety for Coupang's e-commerce platform, ensuring regulatory adherence and risk mitigation across diverse product categories.
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Regulatory Affairs Specialist (Innovation) BdxUSA MD - Sparks - 7 Loveton Circle 1mo Provide regulatory guidance, develop strategies, and conduct risk assessments for new product development teams on in vitro diagnostic (IVD) devices, automated laboratory systems, and related software.
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Regulatory Affairs CMC Manager KenvueEurope/Middle East/Africa, Sweden, Skane, Helsingborg 1mo End-to-end responsibility for Module 3/CMC new product development and life cycle management, acting as the regulatory CMC lead for strategy and deployment.
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Global Product Monitoring Vigilance Report Writer InsuletLondon, United Kingdom 1mo Develops and maintains quality assurance methodologies and systems for post-market vigilance and surveillance of medical devices; serves as a subject matter expert for reportable events and regulatory compliance.
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Senior Device Design Engineer ViatrisLittle Chesterford, England, United Kingdom 1mo Lead assigned programs within the DDI portfolio stream for complex injectables and combination products, managing end-to-end device design, documentation, and regulatory submissions.
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Specialist - Regulatory Affairs - Operations 4A Genpact3601-G-Outsourcing Ser CostaRica S de RL:Ultra park San Jose 1mo Reviewing and managing medical device complaint records to ensure audit readiness and regulatory compliance.
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Principal Human Factors Engineer BaxterBatesville, Indiana $112k–$112k1mo Lead human factors engineering initiatives to improve usability, safety, and efficiency for hospital beds, patient lift systems, and other medical device portfolios.
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Senior Specialist, Regulatory Affairs (Americas & ANZ) ResmedRemote 1mo Develop and execute regulatory strategies for new and existing business channels in ANZ and the Americas, managing premarket registrations and post-market compliance for medical devices and software.
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Sr Manager Regulatory Affairs DexcomSingapore 1mo Develop and champion regulatory strategy for Dexcom's CGM products in the Asia-Pacific region, ensuring compliance and supporting international growth.
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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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Documentation and specification coordinator ZeissgroupMátészalka 1mo Coordinate, create, maintain, and standardize technical documentation, product specifications, and packaging documentation to support global manufacturing and product lifecycle management.
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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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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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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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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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