Regulatory Affairs
735 open positions
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Entwicklungsingenieur in der Medizintechnik (w/m/d (w/m/d) BrunelWürzburg, BAYERN today Managing risk management processes, clinical evaluations, and post-market surveillance for medical devices.
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Sr. Associate - Regulatory Affairs - Operations 5B Genpact1102-G-Dalian: SW Park, Dalian, CN today Manage medical device complaint inquiry records, determine complaint definitions, and conduct due diligence.
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Regulatory Manager SanofiTokyo, JP today Strategic management of development projects and post-marketed products for Japan regulatory CMC & Devices, including submission dossiers, approvals, and liaison with PMDA/MHLW.
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Product Complaint Supervisor BostonscientificAmerican Free Zone, San Francisco de Heredia, Costa Rica | Costa Rica-Heredia 1d Leads and supports the Costa Rica Neuromodulation Complaint Management Center team, overseeing complaint management activities across multiple product portfolios to ensure regulatory compliance and patient safety.
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Product Center Manager FreseniusmedicalcareSuzhou, Jiangsu, China 1d Manage product lifecycle and ensure regulatory compliance for medical devices and digital health products across global markets.
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Sr. Software Engineer - AI Regulatory GehcWuXi, CN 1d AI Regulatory Engineer bridging AI development, systems engineering, clinical workflow, quality systems, and regulatory requirements for AI-enabled medical devices.
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MedTech Clinical Safety Manager IqviaWashington, DC, United States of America $86k–$215k1d Client-facing manager coordinating medical device and combination product safety projects across clinical and post-market programs, ensuring contractual commitments and regulatory compliance.
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Sr Engineering Manager MedtronicTempe, Arizona, United States of America 1d Lead a team of ~15 engineers in final device test engineering for Cardiac, Neuromodulation, and implantable medical applications.
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Dist. Scientist, Regulatory Liaison MsdUSA - Maryland - Rockville 1d Senior regulatory leader developing and overseeing global regulatory strategies for companion diagnostics and in vitro diagnostic (IVD) products to support global registration.
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Senior Engineer - Design Assurance↗ Phillips MedisizeCambridge, England, UK 1d Lead Design Assurance and Risk Management activities to ensure medical devices and drug-device combination products meet quality, safety, and regulatory compliance standards throughout the development lifecycle.
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Senior System Verification Engineer↗ Socode RecruitmentCambridge, England, UK £65k1d Designing and executing robust verification strategies for complex medical technology products, ensuring compliance with regulatory standards.
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Packaging Engineer 2 SmithnephewCHN - Suzhou Plant, CN 1d Lead documentation, design, and project management for packaging and labeling of Wound Management products from concept to launch, ensuring compliance with regulatory and quality standards.
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General Manager - Medical Devices↗ Collins McNicholas Recruitment & HR Services GroupGalway, County Galway, Ireland 1d Lead the commercial and operational development of a growing medical device company, establishing manufacturing operations and driving business growth.
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Ormco Senior New Product Implementation Engineer II (Pomona, CA) EnvistaUnited States of America, California, Pomona $115k–$141k1d Senior engineer supporting new product development and commercialization from feasibility through launch for medical devices.
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Associate Director, Device Regulatory Affairs BiibhrRemote, USA $160k–$220k1d Lead global regulatory strategy and execution for Class III implantable medical devices, managing a team and serving as a senior representative for health authorities.
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Project Engineer↗ VantiveJiutepec, Morelos, Mexico 2d Implementing cost-saving projects, plant maintenance, new products/equipment/processes/materials, and design modifications for manufactured products while ensuring regulatory compliance.
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R&D PDM Jr. Associate↗ Reckitt42, TH 2d Provide ongoing R&D support for medicinal, medical device, cosmetic, and general product portfolios, ensuring technical milestones, documentation, and compliance with regulatory standards.
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Senior Medical Device Project Manager↗ MaternitecDublin 4, County Dublin, Ireland 2d Lead FeMo, a wearable device for passive fetal movement recording, from development through clinical studies, regulatory authorization, and manufacturing to launch.
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Senior Regulatory Affairs & Quality Consultant (Medical Devices & IVD)↗ Ambit IberiaBarcelona, Catalonia, Spain 2d Lead high-impact regulatory and quality consulting projects for medical device and IVD manufacturers, ensuring compliance with EU MDR/IVDR and maintaining Quality Management Systems.
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Director, Engineering Services & Regulatory Affairs↗ Broan-NuToneQuebec, Canada 3d Strategic Director leading global engineering services, regulatory affairs, product quality, and R&D certification labs for residential ventilation solutions.
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Director, Device User Interface↗ ViatrisDublin, County Dublin, Ireland 3d Lead a Human Factors team to translate user needs and use-related risks into robust design inputs for medical devices and drug delivery systems across the development lifecycle.
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Post Market Surveillance Specialist IntuitiveMexicali, MEXICO, mx 3d Investigate customer complaints, perform failure analysis, and ensure completeness of complaint documentation for medical devices.
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English to Latvian Medical Devices Linguist Welo GlobalRiga, Latvia 3d Translate and copy edit medical device and IVD documentation from English (US) into Latvian for regulated global markets.
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Development Engineer↗ Dragonfleye Therapeutics Corp.Toronto, Ontario, Canada 4d Carry assigned ophthalmic device programs through the design-control lifecycle to verification, coordinating vendors, internal engineers, and Quality to ensure evidence and records are complete.
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Design Control Engineer – BONESUPPORT↗ SkånestorLund, Skåne County, Sweden 4d Manage design control, change control, and risk management for medical device product lifecycle, ensuring regulatory compliance and maintaining technical documentation.
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CE RA Director (m/f/d) KenvueEurope/Middle East/Africa, Germany, North Rhine Westphalia, Rhein-Kreis Neuss 4d Leads the Cluster Regulatory Affairs team to ensure successful local deployment of new product registrations, line extensions, and new indications while maintaining compliance with local regulations and quality systems.
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Senior Specialist Quality Assurance AbbottUnited States - New Jersey - Princeton $78k–$156k4d Manages day-to-day compliance with domestic and international regulations, complaint handling, and Medical Device Report (MDR) submissions for medical diagnostic products.
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Global Regulatory Affairs Publishing Specialist BaxterRound Lake, Illinois, US $72k–$99k4d Prepare, publish, and deliver regulatory submissions for life-saving pharmaceutical and medical device products across global markets (US, EU, Canada, Australia) to ensure compliance with health authority requirements.
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Staff Regulatory Affairs Specialist BdxUSA NJ - Franklin Lakes 4d Maintain market access for PreAnalytiX and Lab Specimen Management product portfolios and support new product development regulatory strategies.
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Biocompatibility Engineer ElektaVeenendaal, NL 4d Systems Engineering and biocompatibility expert for Brachytherapy applicators, ensuring medical devices meet safety, quality, and regulatory standards for cancer treatment.
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Product Complaints Specialist MedlinePune, IN 4d Execute product complaint management, investigation, and servicing requests for medical devices, ensuring accurate documentation, tracking, and reporting per regulatory requirements.
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Associate Specialist, Regulatory Affairs EdwardsRemote 4d Support product life cycle management and regulatory submissions for new products, changes, and renewals in the EMEACLA region.
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R&D Project Manager (m/w/d)↗ Pfm Medical Titanium GMBHRemote 4d Lead and steer R&D development projects for medical device product families, ensuring adherence to project goals, schedules, quality, and budget.
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Senior Project Engineer - Medical Devices↗ UL SolutionsMinneapolis, MN, US $103k–$130k4d Conduct safety investigations and compliance evaluations for medical devices, managing project scope, client communication, and laboratory testing coordination.
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Clinical Specialist↗ B. Braun GroupRubí, Catalonia, Spain €40k4d Design, coordinate, and supervise pre- and post-marketing clinical studies to generate evidence supporting the safety and efficacy of B. Braun Surgical products.
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Device Technical Program Lead↗ The Rft Group 4d Lead end-to-end technical programme management and technical leadership for drug delivery devices and combination product development, working with external partners to ensure compliant design controls and robust engineering solutions.
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