Regulatory Affairs
748 open positions
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Principal Regulatory Affairs Specialist BostonscientificMarlborough US-MA, United States | N/A $107k–$203k2mo Principal Regulatory Affairs Specialist supporting global regulatory submissions, compliance, and strategy for medical device product development and new business partnerships.
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Technical Specialist - Active Medical Devices↗ BsiRemote £59k–£78k2mo Review and evaluate medical device technical and clinical documentation to assess compliance with EU and UK regulations, managing certification activities for manufacturers to place active devices on the European market.
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Senior Business Development Executive – Medical Devices SgsShah Alam, Selangor, my 2mo Drive business growth for Medical Device Management & Compliance services through new customer acquisition and expansion of existing accounts.
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Principal Engineer, Contract Manufacturing（首席外协制造工程师） CardinalhealthChina-Shanghai Sourcing Office, Kerry Everbright City 2mo Primary technical leader managing strategic contract manufacturing partners for medical device portfolios including ECG cables, lead wires, electrodes, and wound drain products across the Asia Pacific region.
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Risk Manager Medical Devices (m/w/d) KARL STORZ SE & Co. KGTuttlingen, BADEN_WUERTTEMBERG 2mo Ensure patient safety and product performance across the entire lifecycle of medical devices by managing risks and ensuring regulatory compliance.
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Regulatory Affairs Operations Specialist – Korean Bilingual MedtronicTaguig City, National Capital Region, Philippines 2mo Coordinate regulatory documentation preparation, submission, tracking, and maintenance to support product registrations and compliance across global markets.
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Clinical Manager LumenisYokne'am Illit, Israel 2mo Lead pre-market and post-market clinical activities for medical device platforms, defining requirements, executing validation studies, and generating clinical evidence to demonstrate safety and performance.
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Quality, Nurse Specialist BdxUSA UT - Salt Lake City BAS 2mo Clinical specialist supporting regulatory, clinical, and quality functions for medical devices, acting as a bridge between healthcare professionals and product teams.
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Summer 2027 Internship - RA/QA - Post Market Regulatory Affairs - Virtual StrykerFlorida, Virtual Address 2mo Summer internship in Post-Market Regulatory Affairs supporting global regulatory strategy, compliance, and product registration for medical devices.
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Packaging Development and LCM Specialist↗ Straumann GroupCuritiba, Paraná, Brazil 2mo Develop strategic packaging for dental implants, mapping new technologies and raw materials while ensuring compliance with medical device regulations.
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Regulatory Affairs Expert FreseniusmedicalcareBangalore KA, IND 2mo Manage global regulatory product documentation, ensure compliance with medical device regulations, and lead regulatory strategies for cloud-hosted medical software.
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QA PRODUCT RELEASE SECTION MANAGER↗ GrifolsParets del Vallès, Catalonia, Spain 2mo Manage product release activities for manufactured and distributed products, ensuring compliance with Technical Direction guidelines and regulatory requirements.
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Senior Clinical Development Lead / Senior Medical Safety Physician (m/f/d)↗ RocheVienna, Vienna, Austria 2mo Provide strategic medical leadership for the design, definition, and regulatory clearance lifecycle of Roche's diabetes portfolio, specifically guiding CGM sensors, predictive algorithms, and connected digital health solutions (SaMD).
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?Director, Regulatory Affairs (f/m/d) Estenfeld, BAYERN 2mo 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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Environmental Compliance Program Manager IntuitiveSunnyvale, CA, us 2mo Manage environmental compliance programs and regulated substance databases to ensure product conformance with global regulations for a medical device manufacturer.
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Manager, Field Action Process DanaherSunnyvale, California, United States $130k–$178k2mo 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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Senior Clinical Development Scientist / Medical Safety Manager PhilipsBothell, Washington, United States $149k2mo 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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Global IT Application Lead- Labelling Systems↗ TeleflexCounty Westmeath, Ireland 2mo Manage the global operation, stability, and compliance of the Kallik/Veraciti labeling platform for medical devices, ensuring traceable label content changes across manufacturing sites.
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Principal Device Quality Engineer HeartflowincSan Francisco $190k2mo 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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Senior Engineer II, Device Development BiibhrCambridge, MA $117k–$157k2mo Design, development, and lifecycle management of patient-centric drug delivery devices and combination products.
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Sr Manager, Regulatory Operations - Publishing & Registration Management (Devices) AlconFort Worth, Texas, US $152k–$197k2mo Direct product/process submissions for medical devices to ensure timely global regulatory approvals and maintain compliance.
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Regulatory Affairs Specialist HalmaRemote 2mo Provides customer support on regulatory issues, leads CE marking activities (MDD/MDR), develops 510K submissions, and supports worldwide product registrations.
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VP, Neurology Regulatory Affairs IqviaWashington, DC, United States of America $160k–$445k2mo 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 2mo 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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Senior Device Design Engineer ViatrisLittle Chesterford, England, United Kingdom 2mo Lead assigned programs within the DDI portfolio stream for complex injectables and feasibility projects, managing end-to-end device design (medical device, combination product including packaging and labelling) and associated documentation.
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Konstrukteur/CE-Koordinator (m/w/d) HT Group GmbHHeideck, Mittelfranken, BAYERN 2mo Coordinate and develop the CE conformity process for modular hospital, care, and research construction machinery and systems.
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KMO Director, Clinical Affairs (Brea, CA) EnvistaUnited States of America, California, Brea $177k2mo Senior leadership role bridging clinical strategy, medical/dental affairs, and regulatory functions to define and execute clinical strategy for restorative, endodontics, and disinfection products.
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Senior Manager, Regulatory Affairs (MedTech) FreseniusglobalLake Zurich, IL, US $160k–$170k2mo Senior individual contributor responsible for regulatory decision making and strategy for complex or high-risk products, regions, or regulatory topics.
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Mitarbeiter Entwicklung Medizinprodukte (w/m/d) InnoTERE GmbHRadebeul, SACHSEN 2mo Develop medical devices in synthetic biomaterials for bone replacement from concept to regulatory readiness, ensuring quality management and hygienic standards in cleanroom production.
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Documentation and specification coordinator ZeissgroupMátészalka 2mo Coordinate, create, maintain, and standardize technical documentation, product specifications, and operational knowledge to support global manufacturing and product lifecycle management.
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Sr. Director, Regulatory Affairs EikontherapeuticsJersey City, New Jersey $235k2mo Lead regulatory strategy and compliance for a biopharmaceutical company developing novel treatments using advanced microscopy technology.
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Senior Systems Engineer (all genders) (full-time, regular) AbbVieLudwigshafen, RP, de 3mo 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 3mo Review and document labeling for medical devices, drugs, cosmetics, and commodities to ensure compliance with internal procedures and federal regulations.
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Regulatory Affairs Administrator ElektaWarsaw 3mo Coordinate regulatory block and release activities for assigned Elekta products and spare parts to ensure compliance and timely availability.
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?Entwicklungsingenieur Bad Kissingen, BAYERN 3mo 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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Regulatory & Quality Manager FloyRemote 3mo Transform complex regulatory requirements into practical, scalable solutions to support the development and certification of AI medical devices.
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Senior Microbiologist OutsetmedicalSan Jose - HQ $112k3mo Subject-matter expert for microbiological safety across the product lifecycle, developing strategies, leading testing, and ensuring compliance for medical devices.
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Dokumentationsfachkraft (m/w/d) für dentale Medizinprodukte S&C Polymer GmbHElmshorn, SCHLESWIG_HOLSTEIN 3mo Creating and maintaining user manuals and product documentation for dental medical devices to ensure compliance with regulations.
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