Regulatory Affairs
747 open positions
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Staff Biocompatibility Scientist StrykerGreenwood Village, Colorado, US $92k–$153k15d Lead biological evaluations, risk assessments, and testing strategies for complex medical devices across new product development and sustaining projects.
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Senior Packaging Engineer↗ EPM ScientificMadrid, Community of Madrid, Spain 15d Lead packaging development projects from concept through commercialisation for medical device products, ensuring solutions meet regulatory, quality, and business requirements.
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Regulatory Affairs Specialist II – Structural Heart (on-site) AbbottUnited States - Minnesota - New Brighton $61k–$123k15d Provide support for the regulatory department to ensure efficient and compliant business processes, focusing on product registration documentation and post-market change management.
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?Principal Design Quality Assurance Engineer↗ Palo Alto, CA, US 15d Driving quality initiatives to support product development and lifecycle management for medical devices, ensuring compliance with regulatory standards from concept through commercialization.
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Join Our Talent Pool | Life Sciences, Digital & Compliance Experts↗ Ambit IberiaRemote 15d Ambit Iberia seeks experts to drive digital transformation, regulatory compliance, and operational excellence for pharmaceutical, biotechnology, and medical device organizations across the product lifecycle.
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Advanced Quality & Regulatory Engineer↗ Crux Product DesignCity Of Bristol, England, UK 15d Lead regulatory strategy and device development lifecycle management for novel medical devices and drug-device combination products.
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Regulatory Affairs Specialist GlobusmedicalAudubon, PA, US 15d Performs regulatory assessments for product changes and line extensions, reviews marketing collateral for compliance, and monitors regulatory tracking systems for medical devices.
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Ingénieur Homologation Groupe Technic-AssistanceOise, Hauts-De-France 15d Ensure equipment compliance with various markets and manage regulatory approval activities for new projects.
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Clinical Safety Officer↗ System CNottingham, England, UK 16d Ensure healthcare technology is developed, implemented, and maintained safely for patients and healthcare professionals by acting as a link between clinical practice, product development, and patient safety.
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Engineering Manager↗ Nexxt SpineNoblesville, IN, US 16d Manage the full lifecycle of spinal implant and instrument projects from surgeon concept through 510(k) clearance and production release.
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Medical Devices Safety Facilitator↗ Kims HospitalMaidstone, ENG, GB £6k16d Support the safe management of medical equipment across a hospital by maintaining device registers, coordinating maintenance, and ensuring regulatory compliance.
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Regulatory Manager (labelling)↗ Syneos HealthTS, IN 16d Manage end-to-end regulatory labeling updates, safety signal integration, and submission dossiers for pharmaceutical and medical device products across global markets.
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Lead Research and Development Engineer↗ Cook GroupBloomington, IN, US 16d Technical leader applying engineering principles to solve complex challenges and ensure medical devices meet clinical needs, safety requirements, and quality standards.
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Senior Regulatory Affairs Specialist PhilipsOrange (OH), Ohio, United States $122k–$217k16d Drive regulatory strategies and ensure compliance for Philips CT/AMI medical imaging products across global markets.
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Biomaterials Engineer↗ JellagenCardiff, Wales, UK 16d Lead hands-on product development and delivery of new concepts and innovations relating to the design, testing, and optimization of collagen materials, polymer formulations, and cellular constructs for medical implants, regenerative medicine, and therapeutic…
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Senior Product Complaint Analyst BostonscientificArden Hills US-MN, United States | US-CA-Valencia, US-MN-Arden Hills $72k–$136k16d Analyze customer complaints within the Neuromodulation Division's Complaint Management Center to ensure regulatory compliance, assess patient safety risks, and drive process improvements.
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Senior Clinical Affairs Manager (m/w/d)↗ Karl StorzRemote 16d Develop clinical evidence strategies, evaluate clinical data and scientific evidence, and ensure regulatory compliance for a product portfolio focused on AI-based SaMD.
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Facharzt/-ärztin für die klinische Bewertung von Medizinprodukten (w/m/d)↗ TÜV Rheinland GroupCologne, North Rhine-Westphalia, Germany 16d Evaluate clinical aspects of manufacturer documentation, assess clinical trial results, and perform clinical evaluations of medical devices.
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Associate Director, MDS Regulatory Affairs Systems & Operations BdxUSA NJ - Franklin Lakes 16d Lead MDS Regulatory Affairs systems, operational processes, regulatory data, and enabling capabilities, establishing governance, decision rights, and continuity coverage.
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Quality & Regulatory Affairs Manager (PRRC)↗ Etac GroupAnderstorp, Jönköping County, Sweden 16d Lead the Quality, Testing, and Regulatory Affairs function as the appointed Person Responsible for Regulatory Compliance (PRRC) for a medical device manufacturer, ensuring product safety, regulatory compliance (MDR), and operational excellence.
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Especialista em pesquisa e desenvolvimento↗ Materialise Cmf BrazilRio Claro, São Paulo, Brazil 16d Senior R&D Project Leader developing new medical devices and evolving the product portfolio with a focus on safety, quality, and regulatory compliance.
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Staff Specialist, Regulatory Affairs (16 month contract)↗ BdMississauga, Ontario, Canada CA$85k–CA$135k16d Develop and execute global regulatory strategy for MMS Dispensing products (non-Medical and Medical Devices, Software, Accessories) to support new product development, sustaining, and end of life activities.
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QA/RA, Technical Responsible, PRRC↗ Logic Deimos €31k–€33k16d Lead regulatory compliance strategy and oversee quality management for medical laser devices under EU MDR and FDA regulations.
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Projektleiter:in Regulatory Affairs – Medizinsoftware ZollsoftRemote 16d Leading cross-functional projects to achieve medical software certification under the MDR, coordinating between development, product management, and quality teams.
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Regulatory Affairs & Product Compliance Specialist (m/w/d) ibidi GmbHGräfelfing 16d Ensure products meet regulatory requirements and are internationally compliant, focusing on laboratory equipment and RUO products.
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Senior Principal Scientist, CMC Regulatory Affairs - Combination Products Johnson and JohnsonBeerse, Turnhout 16d Senior scientific and regulatory subject matter expert leading complex combination product regulatory strategies, programs, and processes for pre-approval and post-approval programs.
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Regulatory Submissions Lead II↗ Premier Research 17d Lead regulatory strategy, submissions, and approvals for biotech, medtech, and specialty pharma companies across the study lifecycle, managing Clinical Trial Applications (CTAs) and EU CTIS Part I submissions.
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Biomedical Engineer↗ HufriedygroupRush, NY, US 17d Design, develop, test, and implement innovative processes and products for sterilization packaging and indicators to ensure compliance with regulatory standards and improve patient outcomes.
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Test Engineer↗ VapothermCincinnati, OH, US 17d Plans, executes, and documents verification and validation activities for medical devices to ensure safety, performance, and regulatory compliance throughout the product lifecycle.
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VP, Medical Device Engineering↗ Hims & HersRemote $340k–$380k17d Lead strategy, team, and execution for a regulated medical device portfolio, building the engineering foundation for new consumer medical devices to make preventative care accessible globally.
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Sustaining Engineer↗ Rhythmlink International, LLCColumbia, SC, US 17d Execute improvements to enhance product performance, manufacturability, and regulatory compliance for neurodiagnostic and neuromonitoring solutions.
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Design Assurance↗ RealTipperary, County Tipperary, Ireland 17d Support medical device programmes across new product development, design changes, and design transfer with a focus on Design Controls, MDR Technical File remediation, risk management, and compliant design documentation.
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Sr. Device Development Engineer- Product Design RegeneronRENSS - TECH VALLEY, US $66k–$144k17d Design innovative specialty drug delivery devices and combination products for Regeneron's pipeline.
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Director of R&D - Interventional Medical Devices↗ The Mullings GroupToronto, Ontario, Canada 17d Lead R&D strategy and execution for innovative minimally invasive endovascular devices from concept through commercialization.
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Projektleiter:in Regulatory Affairs – Medizinsoftware zollsoft GmbHRemote 17d Leading certification projects for medical software under the Medical Device Regulation (MDR), coordinating cross-functional teams, and ensuring regulatory compliance.
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Design Assurance Manager (m/w/d) GS Elektromedizinische Geräte G. Stemple GmbHRemote 17d Responsible for Design Assurance of medical devices and software solutions, ensuring release compliance with quality and regulatory requirements, particularly for the US market and FDA.
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Principal Systems Engineer ConvaTecDeeside, Wales, GB 17d Lead systems engineering for complex electrical-mechanical medical devices, specifically negative pressure wound therapy pump systems, ensuring integration of mechanical, electronic, and firmware elements.
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Quality Management & Regulatory Affairs Manager – Medical Devices (m/f/d) Neubourg GmbH & Co KGRemote 17d Ensure medical device portfolio meets quality and regulatory standards, manage QM processes, and maintain audit readiness.
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Quality & Regulatory Affairs Consultant UL SolutionsMéxico 17d Support global consulting services by assisting with medical device registration, licensing, and compliance submissions across multiple regulatory markets.
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Ingegnere Biomedico - appartenente alle categorie protette (L.68/99) ApgroupholdingLanza, Milano 18d Supporto alla progettazione, validazione e sviluppo di dispositivi medici e tecnologie sanitarie, con focus su analisi materiali, test di laboratorio e gestione della documentazione normativa.
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Sr. Associate, Lifecycle Management AlconFort Worth, Texas, US 19d Manage regulatory affairs activities and product lifecycle management to ensure compliance with global and local regulations for medical products.
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Gestionnaire principal(e), Affaires réglementaires CMC AbCelleraVancouver 19d Lead global CMC regulatory affairs for innovative biological products from preclinical to commercialization, ensuring timely submission of high-quality regulatory dossiers to health authorities worldwide.
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Senior Consultant (m/w/d) Regulatory Affairs für Medizinprodukte, Software und KI Johner Institut GmbHRemote 19d Senior Regulatory Affairs Consultant supporting manufacturers in developing safe medical devices, meeting regulatory requirements, and launching innovations internationally via consulting, digital tools, and seminars.
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Regulatory Affairs Manager EnvistaCHE - Kloten - Nobel Biocare, CH 20d Manage regulatory affairs deliverables for prosthetic and digital devices across EU, US, and Canada, including product development, lifecycle management, and compliance projects.
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Sr. R&D Engineer↗ Innovative HealthScottsdale, AZ, US 20d Design, develop, and implement processes and projects for new medical device platforms into production, ensuring compliance with FDA and ISO requirements.
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