Regulatory Affairs
735 open positions
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Systems Engineer↗ Baymar SolutionsOro Valley, AZ, US $85k–$100k4d Define requirements, manage risk, and verify medical device instruments and embedded systems for a client's engineering team.
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Staff Product Development Engineer↗ Sirtex MedicalWoburn, MA, US $124k–$155k4d Senior technical authority leading product development from concept through commercialization for minimally invasive cancer therapies, ensuring design controls, verification, validation, and regulatory submissions.
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Customer Solutions Manager↗ Sage Healthcare Pte. Ltd.Ang Mo Kio, S00, SG 4d Drive alignment between Operations and Customer Service for medical devices, diagnostics, pharmaceuticals, and veterinary products in a regulated environment.
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บQuality and Regulatory Affairs Associate↗ บริษัท เจ เอส วิชั่น จำกัด40, TH 4d Oversee regulatory submission packages, liaise with Thai FDA for approvals, manage product inspections, and maintain documentation for medical device compliance.
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Regulatory Affairs Specialist↗ MedtronicMacquarie Park, NSW, AU 4d Prepare regulatory submissions, maintain licenses, and ensure compliance for medical devices in the Australian market.
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Director Global Biocompatibility and Toxicology Competence Center (m/w/d) FreseniusmedicalcareBad Homburg, Germany 4d Establish and lead a global biocompatibility and toxicology competence center to define and implement safety strategies for medical devices and drug packaging materials, ensuring regulatory compliance and patient safety.
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Sr Regulatory Operation Specialist PhilipsBangalore, IN 4d Manage international regulatory registrations, licensing, and product change notices for medical devices across USA, Canada, and EU regions.
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Clinical Specialist, Post Market Surveillance AbbottUnited States - Massachusetts - Burlington $78k–$156k4d Clinical subject matter expert responsible for global medical device reporting (MDR), investigation of product complaints, and regulatory compliance for heart failure devices.
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Regulatory Postmarket Specialist IntuitiveMexicali, MEXICO, mx 4d Develop post-market strategies, plans, and reports (PMS Plans, PSURs) for medical devices to ensure regulatory compliance and support approvals.
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Intern – Design Assurance Engineer PlexusGuadalajara, Mexico 5d Provide design qualification and engineering support throughout product development and manufacturing lifecycle, serving as the focal point for safety agency and regulatory compliance.
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Regulatory Post Market Surveillance Specialist↗ Intuitive (intuitive Surgical)Mexicali, BCN, MX 5d Investigate customer complaints, perform failure analysis, and ensure completeness of complaint documentation for medical devices.
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Project Engineer - Medical↗ Design OutreachGahanna, OH, US $37k–$52k5d Develop medical devices and WASH technologies for global health, focusing on research, design, prototyping, testing, and field implementation in developing nations.
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Analista Assuntos Regulatórios↗ Adaptprodutos_oficialBarueri, São Paulo, Brazil 5d Regulatory analyst ensuring compliance and maintaining records for medical devices and hospital equipment with ANVISA.
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Analista de Responsabilidade Técnica | Pardis↗ Grupo FleuryVespasiano, Minas Gerais, Brazil 5d Serve as the Technical Responsible Officer ensuring regulatory, sanitary, and technical compliance for health products and operations.
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Regulatory Compliance Specialist↗ Slice D GroupLisbon, Lisbon, Portugal 5d Ensure regulatory compliance and certification for medical devices and digital health solutions while managing public funding applications.
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Jr Project Engineer↗ VantiveJiutepec, Morelos, Mexico 5d Implementing cost-saving projects, plant maintenance, and new product/equipment/process/material implementations while ensuring regulatory compliance and client requirements are met.
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QARA Specialist↗ Gxpeople GlobalRemote £45k–£60k5d Hands-on QA/RA Specialist driving quality system scaling and regulatory compliance for orthopaedic implantable devices from development to market release.
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Analista de Calidad Postmercado↗ BdMexico City, Mexico 5d Monitor post-market surveillance and field actions for medical devices, ensuring regulatory compliance and safety across Latin America.
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Director, MedTech Safety - Europe↗ McRa, an Iqvia Business 5d Lead a team responsible for safety activities supporting Medical Device clinical studies in Europe, ensuring compliance with EU reporting requirements and driving client delivery.
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Sr. Associate, Clinical Research (Non-MD) AlconBangalore, India 5d Author and support clinical evaluation documentation (CEPs, CERs, PMCF Plans/Reports, SLRs) for medical device products, ensuring alignment with EU MDR 2017/745 and regulatory guidance.
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Senior Manager, Combination Products↗ KeenovaDublin, County Dublin, Ireland €75k–€125k5d Principal technical expert for combination-product assets providing leadership in design controls, product quality, engineering, risk management, and lifecycle support.
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Usability Engineer (On-site)↗ Siemens HealthineersShoreview, MN, US $116k–$159k5d Usability Engineer ensuring medical device safety and performance through human factors integration, testing, and compliance with IEC 62366-1 standards.
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Associate Manager Scientist↗ IndegeneJersey City, NJ, US 5d Lead technical evaluation, characterization, and qualification of raw materials (polymers, elastomers, metals, coatings) for medical devices to ensure they meet product, quality, and regulatory requirements.
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Senior Associate, Medical Writing (MD) ClinChoicePhilippines - Pasig 6d Producing Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance (SSCP), State of the Art (SOA), Post-Market Surveillance (PMS) reports, and FDA reports including HDE, IDE, and HEMA research.
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Lead Systems Engineer - Verification GehcWaukesha, US 6d Lead systems engineering and verification/validation activities for next-generation Infant Care Incubators and Warmers to ensure safe, reliable, and compliant medical devices for newborns.
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Research and Development Engineer 1↗ Cook MedicalLimerick, County Limerick, Ireland 6d R&D Engineer supporting project/program activities to solve technical challenges and ensure medical devices meet clinical needs, safety requirements, and quality standards.
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Medical Device Assessor↗ Tüv Rheinland Europe 6d Conducting audits and assessments of medical device Quality Management Systems and technical documentation to ensure regulatory compliance.
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Quality and Regulatory Practice Leader↗ CyientBengaluru, Karnataka, India 6d Primary Subject Matter Expert for Quality and Regulatory Affairs, architecting end-to-end regulatory solutions and go-to-market strategies for medical device product lines.
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Assoc I Quality Product Surveillance,↗ Baxter International Inc.Gurgaon, Haryana, India 6d Manage customer complaints and Medical Device Reports (MDRs), assess product quality issues, and ensure compliance with regulatory requirements for medical devices.
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Regional Clinical Engineer - Masters↗ Shared Health-Soins CommunsWinnipeg, Manitoba, Canada $49k–$64k6d Strategic and operational medical device technology leadership and management for patient-centered clinical and preventive health services.
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Senior System Engineer↗ ActalentDublin, County Dublin, Ireland 6d Senior Systems Engineer leading the development of injector and drug delivery products, translating user needs into design inputs and managing system requirements.
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RAQA Specialist, Singapore↗ Applied MedicalSingapore, Singapore 6d Support regulatory compliance and quality management system (QMS) activities for medical devices across the APAC region, ensuring product registration, distribution, and post-market compliance.
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Evening Shift Production Manager MeritGalway, Ireland 6d Provides guidance and direction for the manufacturing process to meet profitability goals and ensures production needs are met.
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Principal Clinical Scientist, Medical Devices & AI Neko-HealthNew York 6d Own the scientific evidence pathway for medical devices, AI algorithms, and Software as a Medical Device (SaMD) from early concepts through clinical validation and regulatory submissions.
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Senior Regulatory Affairs Specialist StrykerRemote €51k–€85k6d Executes post-market surveillance activities including complaint handling, product field actions, recalls, and commercial holds for medical devices in the GSA region.
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264010 Principal Clinical Engineer↗ Nhs LothianEdinburgh, Scotland, UK 6d Lead a new team in Clinical Engineering and Medical Equipment Management, introducing novel medical devices, managing connected device systems, and overseeing R&D risk assessments.
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Product Development Team Lead↗ Inertia Product DevelopmentToronto, ON, CA 6d Lead medical device projects from concept to manufacturing launch, acting as a primary client contact and fractional CTO for startups and scaleups.
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product development scientist, engineer↗ Theradep Technologies Inc.Youghal, County Cork, Ireland 6d Develop and characterize surface coatings for medical devices (catheters, woven devices) and validate test methods to move products from bench to design transfer.
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