Regulatory Affairs
748 open positions
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Regulatory Affairs Manager PhilipsShenzhen, CN 28d Guide the business through the regulatory landscape for class I and class II medical device and non-medical consumer product groups, ensuring compliance with external regulations and company policies.
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Research Engineer - Patient Evaluation PI-CardiaBoston, United States $150k28d Primary R&D representative in the U.S. for a structural heart device company, managing patient-specific evaluations, complaint investigations, and the US R&D lab.
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Regulatory Affairs Specialist 3, LATAM IntuitiveBarueri, BRAZIL, br 28d Support planning, execution, and maintenance of regulatory activities for medical device product registrations and lifecycle management across Latin America.
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Sr Specialist, Product Safety Risk Management MerativeRemote $121k–$182k29d Owns and maintains ISO 14971-compliant risk management processes for regulated and non-regulated medical imaging software devices across the full product lifecycle.
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Senior Specialist, RA BaxterPetaling Jaya, Selangor, MY 29d Local implementation of regulatory and quality activities to obtain and maintain marketing authorizations for drugs, biologics, and medical devices in Malaysia.
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Specialist, Regulatory Affairs OrganonPHL - Manila, PH 29d Specialist responsible for all aspects of regulatory submissions in the Philippines, managing post-marketing Lifecycle Management (LCM) activities, and ensuring products meet local legislations and company procedures.
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Regulatory Lead - Medical Device Software↗ Raysearch LaboratoriesStockholm, Stockholm County, Sweden 29d Regulatory Lead owning EU MDR strategy and lifecycle compliance for medical device software products treating cancer.
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Global Regulatory Packaging Compliance Leader GehcBengaluru, IN 29d Establish and lead global packaging regulatory compliance frameworks, monitor emerging regulations (EU PPWR, EPR), and translate complex requirements into actionable technical and business strategies for GE HealthCare.
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Head of Product Compliance (f/m/d) OrbemRemote 29d Drive product quality management and regulatory compliance for Orbem's AI-powered MRI systems across EU, US, and global markets, serving as the strategic bridge between hardware/software/AI capabilities and international safety standards.
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Staff Compliance Engineer - Test and Certification StrykerKayseri, Türkiye 29d Lead product safety, compliance, and certification activities for new product development and sustainment projects, working with cross-functional teams and external laboratories.
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Senior Medical Device Regulatory Policy Lead↗
GoogleKA, IN
29d
Drive Google's advocacy in the US and India for medical device features, specifically digital health, healthcare AI, and Software as a Medical Device (SaMD), by facilitating executive-level agency relationships and building policy coalitions.
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Старший специалист по регистрации (Подразделение медицинских устройств) / Sr RA Specialist AbbottRussia - Moscow, RU 29d Senior Regulatory Affairs Specialist preparing and supporting registration dossiers for medical devices and IVD products, interacting with state regulatory bodies to maintain product registration status.
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Global Junior Technical Training Specialist SgsRemote 29d Develop and deliver technical training programs for Medical device segment employees to support conformity assessments in medical device regulations.
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Project Engineer II↗ BiomericsAthens, TX, US 1mo Supports cross-functional engineering and manufacturing projects for medical device development and production.
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Principal Software Design Quality Engineer - Cardiac Rhythm Management & Diagnostics BostonscientificArden Hills US-MN, United States | N/A 1mo Lead design controls, software verification and validation (V&V), risk management, cybersecurity, and regulatory compliance for active implantable medical devices.
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Product Compliance Officer↗ Gv HealthStevenage, ENG, GB £45k1mo Own product regulatory compliance for infection prevention and control solutions (disinfectants, cleaners, waste management) in the healthcare sector, ensuring adherence to regulations like REACH, CLP, BPR, PPE, and medical device standards.
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Labeling Specialist, Global Supply Chain EdwardsUSA - California – Irvine $74k–$104k1mo Manage labeling change requests, design requirements, and workflow for medical device products to ensure compliance and alignment with business strategy.
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Associate Device Development Engineer RegeneronRENSS - TECH VALLEY, US $75k–$123k1mo Execute combination product development projects with responsibilities in project leadership, technical product engineering, design transfer, and secondary packaging.
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Study Director II - Particulate Testing Lab SoterahealthNelson Labs SLC, US 1mo Lead scientific and operational execution of medical device and healthcare testing studies from initiation to final reporting, ensuring regulatory compliance and customer satisfaction.
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Configuration Manager – SAP | Medical Devices & Diagnostics. International Project↗ Alten Delivery Centre SpainRemote 1mo Manage configuration, product documentation, and change control throughout the product lifecycle for medical devices and diagnostics.
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Product Engineer↗ OrganOxMadison, NJ, US 1mo Support design changes, verify implementation, and resolve device performance issues for normothermic machine perfusion systems.
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Regulatory Affairs Engineer/Specialist↗ American OrthodonticsSheboygan, WI, US 1mo Support Engineering and Product Development teams to successfully complete and obtain product registrations for medical devices.
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Regulatory Affairs Specialist - Fuze Services AltoNorthern Cross, IE €45k–€50k1mo Support global regulatory requirements for In-Vitro Diagnostics and Medical Devices across Europe, USA, and Canada, ensuring compliance with marketing authorization, vigilance, and product lifecycle management.
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Human Factors Engineer Sr I↗ ArthrexRemote, US $100k1mo Lead Human Factors efforts for user interface test and development of medical devices throughout the product lifecycle.
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Medical Device & Combination Product Development, Associate Director VrtxBoston, MA, US $172k–$258k1mo Lead the end-to-end development of mechanical, electromechanical, wearable, and connected drug-delivery systems and combination products from feasibility through commercialization.
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Regulatory Affairs Manager (On Site)↗ Myant Shared Service Corp.Mississauga, ON, CA 1mo Develop and execute regulatory strategies for medical devices and Software as a Medical Device (SaMD) across Canada, the US, and Europe.
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Human Factors Lead (Fixed-Term)↗ AlvotechStockholm, Stockholm County, Sweden 1mo Lead human factors strategy, design validation, and regulatory deliverables for a combination products and devices portfolio.
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Senior Medical Director, Integrated Medical Quality and Device Safety AbbVieMaidenhead, England, gb 1mo Senior medical expert providing strategic guidance on benefit-risk evaluations, risk mitigation, and safety signal management for AbbVie's global portfolio of medical devices and combination products.
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HCCO Mexico Johnson and JohnsonCiudad de México, México 1mo Healthcare Compliance Officer providing end-to-end strategic and operational compliance leadership for DePuy Synthes' Orthopedics business in Mexico.
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Product Engineer↗ Merit MedicalSingapore, S00, SG 1mo Validate and verify product design per customer requirements for innovative medical devices.
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Product Engineer↗ Merit Medical Systems, Inc.Singapore, Singapore 1mo Validate and verify product design per customer requirements for innovative medical devices.
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R&D Engineer - Engineering Professional↗ Prosys Fill, IncWebb City, MO, US 1mo Lead engineering product development for advanced biomedical devices, ensuring alignment with design controls, regulatory requirements, and quality standards.
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Regulatory Affairs Associate (m/w/d)↗ Med-ElInnsbruck, Tyrol, Austria €48k1mo Ensuring products comply with regulations and standards by providing strategic input for product development, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes.
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Project Manager (m/w/d) GS Elektromedizinische Geräte G. Stemple GmbHRemote 1mo Leading cross-functional teams to deliver defibrillator product roadmaps, ensuring regulatory compliance and clinical utility for emergency medical services.
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Entwicklungsingenieur Materialtechnologie (w/m/d) Aesculap AGTuttlingen, BADEN_WUERTTEMBERG 1mo Develop and optimize material specifications and documentation for medical devices, focusing on polymers and metals.
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Technical Steward - Devices↗ Novartis India 1mo Provide technical leadership for medical devices and drug-device combination products throughout their lifecycle, ensuring compliance and reliable product delivery.
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Quality Assurance - Design History File↗ Madhu InstrumentsDL, IN ₹480k1mo Ensure compliant compilation, documentation, and maintenance of Design History Files (DHF), Design Files, and Technical Documentation for medical devices.
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Sr. Product Development Engineer↗ Arch Medical SolutionsKenosha, WI, US $120k1mo Lead the design, test, modification, and assembly of medical device prototypes while ensuring manufacturability and quality compliance.
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