Regulatory Affairs
748 open positions
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Vice President, Operations | Aetherus Health NlcventuresPittsburgh, Pennslyvania 1mo Own the full non-commercial path from product to patient for a pocket-sized positive pressure medical device, driving US launch in Q3 2027.
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?Engineer II, Product Development↗ Miami, FL, US 1mo Execute product development for medical devices and biologics, ensuring compliance with regulatory requirements (FDA, ISO) and managing design controls, risk, and validation.
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Technical Steward - Devices NovartisHyderabad (Office), IN 1mo Provide technical leadership for medical devices and drug-device combination products throughout their lifecycle, ensuring they are fit for purpose, compliant, and capable of supporting reliable product delivery.
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Project Manager, Implementation SyndigoRemote 1mo Own end-to-end implementation of Syndigo's healthcare and medical device connections, acting as the primary point of contact for clients from kickoff through go-live.
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FMI Lead Program Integrator GehcIND19-01-Bengaluru-EPIP 122 (Phase II), IN 1mo Lead end-to-end execution of complex Field Medical Intervention (FMI) and Recall programs in a highly regulated medical device environment, ensuring closure readiness and compliance.
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Staff Engineer↗ BdFranklin Lakes, NJ, US $136k1mo Technical leader for sustaining engineering of commercially released medical devices, ensuring lifecycle management, compliance, and global portfolio success.
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Senior Manager, Global Clinical Strategy SmithnephewUS - Field $126k–$188k1mo Lead the development and execution of clinical and economic evidence strategies to support market access, new product development, and registration for the Knee Robotics franchise within Orthopaedics.
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Regulatory Affairs Specialist DanaherRemote 1mo Obtain and document mission-critical Indian regulatory clearances for medical device products and manage international/domestic filings for the APAC region.
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Product Development Engineer↗ KimalBromsgrove, England, UK 1mo Develop and improve medical Procedure Pack products from concept through to manufacture, ensuring quality, safety, and regulatory compliance.
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Risk Manager↗ AbbottIrving, TX, US $99k–$199k1mo Develop and implement quality systems and procedures for product risk management to support smarter medical and economic decision-making in diagnostics.
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Principal Regulatory Affairs MedlineRemote $116k–$174k1mo Develop global regulatory strategies for new product approvals and maintain existing products in the medical device industry.
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Senior Systems Engineer AbbVieNorth Chicago, IL, us 1mo Lead systems engineering for drug/device combination products, integrating multiple disciplines to ensure robust patient-centric design and performance.
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Principal Regulatory Affairs Specialist HeartflowincRohnert Park $188k1mo Drive global regulatory strategy and submissions for AI-driven medical products (SaMD, AI/ML algorithms, mobile medical apps) to achieve commercial clearance.
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Leitung Quality Assurance/ Regulatory Affairs (m/w/d) Cardiobridge GmbHHechingen, BADEN_WUERTTEMBERG 1mo Lead Quality Assurance and Regulatory Affairs for a minimally invasive circulatory support system for patients with acute heart failure.
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Engineering & Science - Safety Engineer ElektaChangping, Beijing, CN 1mo Ensures Elekta Imaging products are developed and released in compliance with safety standards, regulatory requirements, and Quality Management System processes throughout the product lifecycle.
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Lead System Designer - CT↗ GE HealthCareBengaluru, Karnataka, India 1mo Lead system design and development for Hybrid CT imaging devices, ensuring design outcomes meet quality, regulatory, and performance requirements.
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Hardware Compliance Engineer IntuitiveSunnyvale, CA, us 1mo Drive EMC/wireless compliance and safety test support for Intuitive Surgical's robotic-assisted surgery products, leading interactions with outside labs and agencies.
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Regulatory Affairs Specialist – Medizintechnik (m/w/d) ewimed GmbHRemote 1mo Create and maintain technical documentation and regulatory files for medical devices, ensuring compliance across the product lifecycle.
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Device Project Coordinator EurofinsCambridge, England, gb 1mo Provide project management support for parenteral combination product developments, ensuring quality, cost, and schedule targets are met.
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Sr. RA Associate Consultant ClinChoiceRemote 1mo Sr. Regulatory Affairs Consultant creating and updating Technical Documents (TDs) for medical device clients in compliance with EU MDR and global regulations.
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Technical Program Manager Plutus21Remote 1mo Coordinates the development of a medical device across hardware, optics, software, imaging, systems engineering, quality, regulatory, clinical and manufacturing workstreams.
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Regulatory Project Manager - FSP - EMEA ThermofisherRemote, Belgium 1mo Senior Manager of Regulatory Affairs leading strategic initiatives for global regulatory compliance across medical devices, pharmaceuticals, biologics, and in-vitro diagnostics.
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Milestone & Change Support Senior Specialist↗ RocheSant Cugat del Vallès, Catalonia, Spain 1mo Advising and supporting R&D units in Diagnostics on planning, tracking, and preparation of product development documentation for design control and regulatory requirements.
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Quality and Regulatory Affairs Manager Medical Devices (m/f/d) D.MED Consulting GmbHHamburg, HAMBURG 1mo Ensuring regulatory compliance and quality management for medical devices through gap analyses, technical documentation, and risk management.
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Entwicklungsingenieur Elektronik Lifecycle Management Medizintechnik (all gender) AltenRemote 1mo Electronic lifecycle management engineer responsible for analyzing electronic assemblies, managing component obsolescence, and ensuring regulatory compliance for medical device products.
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Senior Research and Development Engineer↗ Cook GroupBloomington, IN, US 1mo Technical leader and subject matter expert applying engineering principles to solve complex challenges, develop innovative medical devices, and ensure products meet clinical needs and safety requirements.
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R&D Quality Manager↗ Sandoz UK & IrelandCambridge, England, UK 1mo Manage complex and late-phase projects for Drug Delivery Device Development, ensuring compliance with cGMP and regulatory standards.
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Staff Regulatory Affairs Specialist - Pharma BdxUSA IL - Vernon Hills 1mo Managing regulatory activities for new and existing combination devices and/or pharmaceuticals, including healthcare antiseptic products, with direct interaction with FDA CDER.
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Senior Design Quality Engineer BaxterMarsa, Malta €32k1mo Provide technical support and service for all aspects of quality engineering while ensuring compliance with safety standards and global regulatory requirements for medical devices.
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Regulatory & Quality Affairs Manager NanoxPetah Tikva, Israel 1mo Lead global regulatory strategy and quality operations for Software as a Medical Device (SaMD) products, ensuring compliance with international regulations throughout the product lifecycle.
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Staff Regulatory Affairs Specialist (Hybrid) StrykerRedmond, Washington, US $110k–$183k1mo Guide regulatory activities across product development, product changes, and lifecycle management for emergency care medical devices to ensure compliance and market availability.
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Regulatory Affairs Manager MedtronicLafayette, Colorado, United States of America 1mo Establish strategies for worldwide product approval and submission activities, directly executing submissions for the U.S. and EU, and ensuring regulatory compliance for Lung Health and Gynecologic products.
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Engineer (m/w/d) Product Innovation GetingeRemote 1mo Develop new cardiopulmonary disposable medical devices for heart surgery and intensive care, focusing on user and patient needs.
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Systems Engineer (m/w/d) in der Medizintechnik MELAGBerlin, BERLIN 1mo Define product requirements from customer to technical levels, perform system analysis and modeling using SysML, and support the development of medical devices including usability evaluations and risk management.
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Senior Regulatory Affairs Specialist NateraRemote $83k1mo Prepare regulatory submissions for new and modified medical devices and in vitro diagnostic devices to secure market clearance/approval in domestic and international markets.
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Product Safety and Compliance Engineer III PelotonWoodinville Office $109k1mo Lead technical role ensuring connected fitness products meet safety, quality, and regulatory compliance standards throughout their lifecycle.
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Design Quality Engineer Bien-Air Surgery SASchweiz 1mo Ensure design quality and regulatory compliance for high-tech microsurgical instruments throughout New Product Development and design changes.
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Senior Manager, Regulatory Affairs Azurity PharmaceuticalsRaleigh, NC 1mo Oversee regulatory activities for assigned pharmaceutical products and projects, serving as the regulatory representative on cross-functional teams to ensure compliance and drive registration strategies.
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