Regulatory Affairs
748 open positions
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Segment Manager Medical Devices Benelux SgsAntwerpen, Vlaanderen, be 1mo Strategic and commercial leader responsible for the growth, profitability, and overall development of the Medical Devices business across Belgium and the Netherlands.
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System Engineer↗ Luxshare-IctSingapore, Singapore 1mo System Engineer supporting client medical device development programs by translating user needs into engineering requirements and managing system integration, verification, validation, and design transfer.
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Senior Specialist, International Regulatory Affairs TMTT EdwardsUSA - California – Irvine $92k1mo Create complex regulatory submissions for Transcatheter Mitral and Tricuspid Therapies (TMTT) products to guide innovative technologies through domestic and international regulatory environments.
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Usability Engineering Lead Neko-HealthStockholm 1mo Lead usability engineering and human factors activities for medical device product development, ensuring safety and usability from concept through verification.
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Senior Systems Engineer AbbVieNorth Chicago, IL, us 1mo Lead systems engineering for drug/device combination products, ensuring robust patient-centric design, integration of third-party activities, and regulatory compliance.
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Project Manager (m/w/d), corpuls Kaufering (Hauswiesenstraße) CorpulsKaufering, BAYERN 1mo Leading cross-functional teams to deliver defibrillator products for emergency and intensive care medicine, ensuring regulatory compliance and patient impact.
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Staff Systems Engineer FortiveIrvine, CA, United States $158k–$263k1mo Provides advanced technical leadership and hands-on systems engineering support for the design and development of complex medical device systems, translating requirements into executable designs.
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Senior Regulatory Affairs Specialist (Hybrid - Acton, MA) InsuletActon, Massachusetts, US $92k–$138k1mo Lead regulatory affairs activities to support domestic and international registrations and submissions for medical devices.
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Systems Engineer - Health Software AppleSunnyvale, United States of America 1mo Develop, manage, and maintain design history files and regulatory deliverables for Apple's regulated health software features.
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Staff Research Scientist AbbottUnited States - California - La Jolla 1mo Lead Design Control for developing new regulated molecular diagnostic products and managing lifecycle of existing products, ensuring compliance with FDA and global regulatory standards.
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Director, Regulatory Affairs ElementbiosciencesSan Diego - Headquarters $152k1mo Build and lead global regulatory strategy for in vitro diagnostic (IVD), next generation sequencing (NGS), and regulated life science instrumentation products to support market authorization and commercial expansion.
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Manager Regulatory Affairs (m/f/d) NovantaBerlin, Germany 1mo Manage regulatory submissions and approvals for medical devices to ensure timely market placement and compliance throughout the product lifecycle.
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Design Assurance Manager (m/w/d) GS Elektromedizinische Geräte G. Stemple GmbHRemote 1mo Responsible for Design Assurance of medical devices and software solutions, ensuring release compliance with quality and regulatory requirements (EU and FDA).
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Human Factors and Usability Engineering Director SanofiMorristown, NJ, US 1mo Lead complex Human Factors and Usability Engineering (HF/UE) programs for drug delivery devices (Insulin Pens, Autoinjectors, etc.) across the full product lifecycle, ensuring regulatory compliance and user-centered design.
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Regulatory Affairs Specialist I | Perú BostonscientificLima PE-LIM, Peru | N/A 1mo Support medical device regulatory activities by coordinating submissions, maintaining documentation, and managing product lifecycle activities including registrations and renewals for Andean markets.
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Director, Research and Development StrykerTempe, Arizona $156k1mo Leading Stryker Sustainability Solutions innovation, product development, and regulatory strategy to deliver sustainable business growth.
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CE-Koordinator (m/w/d), HBC-radiomatic GmbH, Haller Straße 45-53, 74564 Crailsheim HBC-radiomatic GmbHCrailsheim, BADEN_WUERTTEMBERG 1mo Evaluate international legal requirements for products and support the conception, development, and market launch of new products.
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Regulatory Affairs Specialist PI-CardiaRehovot, Israel 1mo Drive global regulatory strategies and ensure compliance for cardiovascular medical devices throughout the product lifecycle.
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Manager – APAC Regulatory and Market Access AvaniaSydney, New South Wales 1mo Lead regulatory strategy and market access for medical devices in Australia, serving as the primary point of contact for clients and coordinating with global teams.
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Senior Regulatory Affairs Specialist EnovisBrisbane, Queensland 1mo Develop and execute regulatory strategies for innovative medical devices, software, and AI-enabled technologies to bring them to market across the US, Europe, and Australia.
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Manager:in für Produktzulassungen (m/w/d) Zirkonzahn GmbHItalia 1mo Manage regulatory strategies and documentation for global medical device approvals, ensuring compliance with national and international regulations.
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Senior Manager - Regional RA/QA (m/f/d)↗ Karl StorzSingapore, Singapore 1mo Lead regional Regulatory Affairs and Quality Assurance for medical diagnostic equipment, ensuring compliance with ASEAN and international standards while managing product registration and audits.
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Sustaining Design Quality Engineering Manager SmithnephewMansfield, MA 1mo Lead a team of Sustaining Design Quality Engineers to support Joint Repair products across their lifecycle, ensuring safety, effectiveness, and compliance.
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Principal R&D Engineer CardinalhealthMA-Mansfield-West Building $108k–$154k1mo Technical leader responsible for the design, development, verification, validation, commercialization, and lifecycle management of medical device products.
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Project Manager, Regulatory Affairs / Quality Assurance IntuitiveSunnyvale, CA, us 1mo Strategic project management partner for Regulatory Affairs & Quality Assurance leadership, executing regulatory strategies and quality-assurance readiness across drug development programs from clinical development through marketing application submission and…
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Verification & Validation (V&V) Manager Eitan MedicalNetanya, Israel 1mo Lead the Verification & Validation (V&V) function and strategy for new drug-delivery and infusion medical devices, ensuring risk-based test coverage and traceability from requirements to final reports.
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Associate Regulatory Affairs Specialist - 18 months contract MedtronicBrampton, Ontario, Canada $64k1mo Coordinate regulatory submissions, license renewals, and labeling compliance for medical devices to ensure timely market approvals.
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Expert Global Human Factors Engineering FreseniusmedicalcareSuzhou, Jiangsu, China 1mo Lead human factors engineering for hemodialysis medical devices (active and non-active, Class II/II) to ensure usability and safety across global markets.
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Regulatory Affairs Director ISA GehcIND36-01-Bengaluru-Kalyani Platina, Magnolia, IN 1mo Provides regulatory strategy and direction for healthcare product launch, premarket submissions, and postmarket compliance, working closely with global healthcare regulatory bodies.
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Development Engineer↗ Phillips MedisizeCambridge, England, UK 1mo Lead the translation of design input requirements into design specifications, implementation, and design proof for smart inhalation and nebuliser systems, ensuring medical devices meet performance, safety, and regulatory requirements.
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Research and Development Engineer 2↗ Cook MedicalLimerick, County Limerick, Ireland 1mo Technical leader applying engineering principles to solve challenges and ensure medical devices meet clinical needs, safety requirements, and quality standards.
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Senior Regulatory Associate New Product Development and Medical Devices↗ Fresenius Kabi CanadaToronto, Ontario, Canada $90k–$100k1mo Senior Regulatory Associate supporting new product development for pharmaceuticals and medical devices by managing regulatory submissions and assessments for Health Canada.
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Technischer Redakteur (m/w/d) Medizintechnik WILAmed GmbHKammerstein, BAYERN 1mo Creating, maintaining, and updating user manuals, product information, and technical documentation for medical devices used in respiratory patient care.
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Senior Software System Engineer ElektaVeenendaal 1mo Lead requirements, specifications, and R&D documentation for medical device software development, ensuring compliance with regulations and cybersecurity standards.
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Regulatory Affairs Manager (m/w/d) Hormosan GmbHRemote 2mo Managing national and European regulatory approval procedures (DCP, MRP, RUP) for pharmaceuticals, medical devices, supplements, and cosmetics.
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Senior Medical Device Quality & Regulatory Engineer Flow Neuroscience ABMalmö, Sweden 2mo Senior Medical Device Quality & Regulatory Engineer owning QA, QMS, and regulatory infrastructure for a neuromodulation device treating major depressive disorder.
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Produktmanager/in Leonhard Lang GmbHRemote €41k2mo Technical product support for medical devices throughout their lifecycle, focusing on technical documentation, change management, and coordination of product-related tasks.
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