Regulatory Affairs
735 open positions
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Project Manager (18 months FTC) ResmedSingapore, Singapore 8d End-to-end coordination and delivery of product lifecycle engineering projects for medical devices, ensuring on-time delivery within specification.
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R&D Packaging Engineer III↗ ConMedLargo, FL, US 8d Define innovative medical device packaging products, develop novel concepts and designs, lead verification and validation testing, and transfer new devices to manufacturing.
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Transfer Project Manager – Global Manufacturing Ramp-up (f/m/x) ZeissgroupOberkochen, DE 8d Lead the end-to-end ramp-up and transfer of a new global medical device manufacturing site, ensuring supply continuity and regulatory compliance.
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Manager for Product Development↗ Sree Guru Precision Manugacturing Solutions Opc Pvt.Ltd(sgmps)TS, IN ₹600k–₹1000k8d Manage new product development activities from concept to final product for electromechanical medical devices.
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Senior Compliance Engineer↗ Siemens HealthineersNewton, MA, US $118k–$163k8d Lead compliance engineering and product safety strategy for medical devices across the Monadnock program and other product development efforts.
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Manager Clinical Affairs↗ Aspire Life Sciences SearchBerlin, Germany 8d Managing clinical evaluation, regulatory evidence generation, and post-market clinical activities for cardiovascular and inflammation-related medical devices.
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Head of Vigilance & Safety (m/w/d)↗ Heraeus MedicalWehrheim, Hesse, Germany 8d Lead the global vigilance system for medical devices (up to Class III), ensuring safety throughout the product lifecycle by evaluating adverse events, coordinating safety reports, and managing regulatory compliance.
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Senior Medical Device Cybersecurity Specialist – EU Regulations↗ UL SolutionsBarcelona, Catalonia, Spain 45k8d Develop and maintain deep expertise in global medical device cybersecurity regulations, standards, and conformity assessment requirements to provide advisory support and drive business growth.
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Quality specialist, R&D↗ Umano MedicalQuebec, Canada 8d Coordinating product risk management, verification and validation strategies, and leading approval of new medical products.
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Especialista em Qualidade e Assuntos Regulamentares, Dispositivos Médicos (m/f)↗ Ultra ControloSintra, Lisbon, Portugal 8d Lead technical documentation and regulatory compliance for medical gas devices (classes IIa/IIb) under the EU MDR, managing risk, post-market surveillance, and quality system maintenance.
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Senior Regulatory Affairs Associate↗ Clarion Medical TechnologiesCambridge, Ontario, Canada $68k–$72k8d Ensure global regulatory compliance, support EU MDR projects, and manage technical documentation for medical device submissions and audits.
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Senior Product Development Engineer↗ FemtherapeuticsMontreal, Quebec, Canada 8d End-to-end development of a home-use pessary for pelvic organ prolapse and postpartum recovery, leading from verification through design transfer for FDA/Health Canada submission.
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Regulatory Affairs Analyst (Temporary position) (Based in Ciudad de Mexico)↗ Edwards LifesciencesMexico City, Mexico 8d Completes and maintains regulatory approvals and clearances for medical devices, creates regulatory submissions, and tracks timelines for product distribution.
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Systems Test Engineer↗ ActalentMontreal, Quebec, Canada $83k–$104k8d Remediate system and software test requirements for catheter medical devices to ensure FDA compliance.
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Regulatory Program Manager, Health AppleCupertino, United States of America 8d Drive global launch of regulated health features and manage regulatory submissions, quality systems, and policy engagements for health products.
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R&D Verification Validation Engineer↗ Biocon BiologicsBengaluru, Karnataka, India 8d Ensuring medical device products are designed, developed, verified, and validated in accordance with global regulatory and quality standards.
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QA & RA Officer↗ NicolabMelbourne, Victoria, Australia 8d Ensure Nicolab's quality management system and product registrations comply with international medical device regulations (ISO 13485, EU MDR, FDA QMSR) to enable safe deployment of AI-powered stroke imaging software.
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Consultant (m_w_d) Medical Devices↗ NsfHamburg, Hamburg, Germany 8d Consultant supporting medical device manufacturers and suppliers with regulatory strategies, quality management systems, and technical documentation to ensure safe market entry.
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Compliance Specialist II - Regulatory Affairs ThermofisherOttawa, Canada $56k–$85k8d Ensure products and operations comply with Canadian and international regulatory requirements, supporting product onboarding and business continuity.
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Operations Manager Medical Devices↗ Tech Skills Resources (part of the Cpl Group)Limerick, County Limerick, Ireland 9d Lead daily operations, quality, and regulatory compliance for a medical device company in a regulated environment.
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Senior R&D Product Engineer↗ Life Science RecruitmentGalway, County Galway, Ireland 9d Lead R&D projects for a medical device retrieval system from concept through regulatory approval and commercial scale-up.
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Medical Device Development Lead↗ Suma MedtecKufstein, Tyrol, Austria 9d Lead medical device design initiatives across the full product life cycle, focusing on Device Technology, Risk Management, and Usability.
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Regulatory Affairs Specialist - MedTech (f/m/x)↗ Sii PolandStockholm, Stockholm County, Sweden 10d Ensure medical devices comply with global regulatory requirements and streamline regulatory processes.
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Sr RA Specialist, APAC Indirect Mkts IntuitiveKuala Lumpur, MALAYSIA, my 11d Execute regulatory strategy for obtaining registration approval of medical devices in APAC indirect markets.
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Director, MedTech Safety - Europe↗ IqviaBarcelona, Catalonia, Spain 310k11d Lead safety activities for Medical Device clinical studies in Europe, ensuring compliance with EU reporting requirements and managing a team of Safety Specialists and Managers.
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Director Global Quality, Regulatory & Clinical (QRC) (m/f/d)↗ RevvityLübeck, Schleswig-Holstein, Germany 11d Global leader integrating Quality, Regulatory, and Clinical Affairs to drive IVD product lifecycle, IVDR transition, and FDA pathways.
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Post Market Surveillance Specialist↗ Fresenius Medical CareReynosa, Tamaulipas, Mexico 11d Receive, review, document, and process product complaints and inquiries for dialysis medical devices in compliance with regulations and quality standards.
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Clinical Affairs Project Lead DanaherRemote 11d Plan, execute, and deliver clinical affairs activities to generate and maintain clinical evidence supporting global market access and product lifecycle management for medical devices and IVD.
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Regulatory Affairs Specialist II – Lingo (on-site) AbbottUnited States - California - Alameda $82k–$141k11d Prepare regulatory submissions and documentation for medical device product market entry, ensuring compliance with FDA and international regulations.
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Director, R&D Quality Assurance AlconLake Forest, California, US $184k–$238k11d Lead strategic quality assurance governance for surgical ophthalmic devices, ensuring compliant product development, regulatory submissions, and lifecycle management.
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Quality Assurance Manager, Medical Device & Combination Products PfizerUnited States - Missouri - St. Louis - Chesterfield $99k–$165k11d Strategic quality oversight for Medical Device and Combination Products (MDCP) portfolios across 50+ markets, ensuring compliance with international regulatory standards and patient safety.
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Senior Manager, Global Process, Systems & Center of Excellence MedlineNorthfield, Illinois, US 11d Lead and manage global postmarket processes including complaint management, investigations, failure analysis, device vigilance, regulatory reporting, and pharmacovigilance to ensure regulatory compliance and process standardization across Medline's product…
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Product Safety Engineer I - Medical Devices↗ CSA GroupIrvine, CA, US $71k–$93k11d Certify new and leading-edge medical device products and systems for safety compliance against national and international standards.
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Clinical Affairs Project Lead↗ Leica MicrosystemsRemote 11d Planning, execution, and delivery of clinical affairs activities to generate and maintain clinical evidence for global market access and product lifecycle management in medical devices/IVD.
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Sr. Post-Market Surveillance Analyst↗ AirlifeGrand Rapids, MI, US 11d Leads the recall and field action process and serves as the primary resource for adverse event reporting and vigilance activity under global regulatory requirements.
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Staff Engineer, Software V&V↗ Thermo Fisher ScientificKA, IN 11d Lead software verification and validation strategy, design, and execution for advanced bioinformatics and NGS analytics software in a regulated medical device environment.
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CER Technical Medical Writer↗ Kelly Science, Engineering, Technology & Telecom 11d Create, update, and manage regulatory and clinical documents (CERs, SSCPs, SOAs, LRRs) for orthopaedic medical devices.
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Product Reviewer – Contractor↗ JobgetherRemote 11d Independently assess technical documentation and software lifecycle processes of medical device software (SaMD and AI-enabled) to ensure compliance with regulatory and safety requirements.
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Senior Packaging Engineer Phaidon EPM LondonMadrid 12d Lead packaging development projects from concept through commercialisation for medical device products, ensuring solutions meet regulatory and business requirements.
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Manager - Regulatory Affairs Sun PharmaVadodara, Gujarat 12d Lead regulatory activities for US, EU, and Canada markets for complex generic and drug-device combination products.
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Principal Regulatory Affairs Specialist BostonscientificValencia US-CA, United States | US-CA-Valencia, US-MN-Arden Hills, US-MN-Maple Grove, US-CA-Santa Clara $107k–$203k12d Develop and execute regulatory strategies for innovative medical devices, managing submissions to the FDA and EU notified bodies.
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Senior Regulatory Affairs Specialist MedtronicNanakramguda, Hyderabad, India 12d Lead regulatory affairs activities for medical device projects, managing global submissions, regulatory strategies, and compliance with health authorities.
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Senior Director, Device Portfolio and Business Development ViatrisNorthern Cross, Dublin, Ireland 12d Leading global device portfolio strategy, business development, and technology assessment for medical devices and combination products.
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QA/RA Specialist, Biological Materials / Animal Tissue↗ Biosensors International Group, LtdHechingen, Baden-Württemberg, Germany 12d QA/RA Specialist ensuring regulatory and quality compliance for animal-derived biological materials in Class III cardiovascular devices.
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