Regulatory Affairs
414 open positions
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R&D Engineer II (Medical Devices)- HYBRID (Alpharetta, GA) OwensminorOMI Alpharetta Lab $85k–$85k3mo Lead R&D activities for medical apparel products, defining requirements, prototyping, and developing manufacturable designs.
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Urologist / General surgeon for the Centre of Clinical Evaluation (f/m/d) Tüv SüdMünchen, München (Kreis) 3mo Assessing clinical evaluations and technical documentation for medical devices to ensure compliance with the European Medical Device Regulation (MDR).
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Regulatory Affairs Medical Devices Officer Biofarma GroupLissone, Provincia di Monza e Brianza 3mo Regulatory Affairs Officer specializing in medical devices, managing technical files, registrations, and compliance documentation for Biofarma Group's device portfolio.
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Global Technical Manager – Sterilization SgsRemote 3mo Lead a global team of MDR Product Assessors and sterilization auditors to oversee sterilization processes and provide technical support for medical device conformity assessments across MDR, MDD, UK MDR, ISO13485, MDSAP, and IVDR schemes.
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RA manager ThermofisherTokyo, Japan 3mo Lead regulatory strategy and compliance for imported IVDs, medical devices, and research reagents in the Japanese market, ensuring adherence to the PMD Act and managing post-market activities.
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Project Manager PhilipsShenyang 3mo Lead cross-functional teams to achieve system program objectives in the medical device industry.
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Senior Project Manager Medical Devices Zeiss IndiaBangalore, Karnataka 3mo Translating business objectives into baselined plans with identified milestones, coordinating resources across departments, and ensuring deliverables meet quality and regulatory standards within the medical device industry.
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Director, Site Lead Combination Product Development, R&D AbbVieNorth Chicago, IL, us 3mo Lead the Lake County Combination Product Development (CPD) team to drive clinical development of combination products including prefilled syringes, autoinjectors, on-body injectors, and subcutaneous ambulatory infusion pumps.
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Regulatory Affairs Specialist - Medical Devices Vueverse.India 3mo Provide regulatory strategy and guidance for medical device products across global markets, preparing submissions and ensuring compliance with FDA, EU MDR, and ISO standards.
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Regional Regulatory Affairs Lead, EMEA Neko-HealthLondon 3mo Build the EMEA Regulatory Affairs function from the ground up, manage relationships with MHRA and other authorities, and hold the UK Responsible Person role.
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Senior Regulatory Executive - Medical Device Maven Profcon Services LLPAhmedabad, Gujarat 3mo Develop, review, and maintain regulatory documentation for medical devices in accordance with EU MDR and FDA requirements.
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Associate Director, Regulatory Legal Counsel IlluminaEngland - Cambridge $111k–$166k3mo Provide strategic legal advice on regulatory requirements for medical devices, diagnostics, and life science products across EMEA and Latin America.
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Clinical Evaluation Specialist CapijobnewRemote 3mo Conduct detailed clinical assessments of medical devices to ensure safety and performance compliance with European regulations, compiling Clinical Evaluation Assessment Reports (CEARs) and managing submissions to the EU Commission.
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Customer Success Manager, Medical Devices LumafieldSan Francisco, CA 3mo Drive customer outcomes and revenue growth for Lumafield's industrial CT scanning and manufacturing technology products by serving as a trusted advisor and managing the complete customer lifecycle.
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Associate Director Regulatory Affairs – Vascular (on-site) AbbottUnited States > Massachusetts > Westford : 4 Robbins Road $129k–$129k3mo Sets strategy and directs preparation of regulatory submissions to obtain timely approval for vascular medical devices and software.
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Regulatory Expert, Digital Pathology AgilentRemote $124k–$124k3mo Provide strategic and tactical regulatory leadership for digital pathology products, including software, image analysis algorithms, and integrated diagnostic systems.
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Head of Quality, Device and Combination Products BiibhrCambridge, MA 3mo Lead global quality strategy and operations for medical devices and combination products, ensuring compliance and lifecycle management from design to supply.
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Staff Sterilization Specialist (Hybrid, Acton MA) InsuletUS - Massachusetts $130k–$130k3mo Senior technical expert providing scientific leadership and decision-making for global sterilization processes, specifically ethylene oxide (EO) and alternate modalities.
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Eng II, Systems C&S BaxterBangalore, Karnataka 3mo Design and development of electro-mechanical medical device solutions for respiratory and cardiac care, ensuring compliance with global safety and regulatory standards.
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Device Project Lead↗ Sandoz UK & IrelandCambridge, England, UK 3mo Lead device projects for combination products and standalone medical devices, ensuring compliance with regulatory standards and operational excellence.
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Regulatory Affairs Senior Specialist - Supply Chain Projects ResmedSingapore, Singapore 3mo Primary regulatory point of contact for Supply Chain projects, assessing regulatory risks and driving compliance for operational changes in manufacturing and distribution.
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Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors TakedaBoston, MA $212k–$212k3mo Lead the development and implementation of innovative regulatory strategies for pure devices and drug-device combinations, with a specific focus on Human Factors to ensure high-quality regulatory filings.
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Senior Lead Specialist, Regulatory Affairs, AKA GehcBangkok 3mo Provides regulatory strategy and guidance for product launches, pre-market submissions, and post-market compliance for the Thailand healthcare business.
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EAS Gas Director SoterahealthRemote 3mo Leads gas-related Expert Advisory Services (EAS) projects, ensuring technical execution, regulatory compliance, and customer satisfaction in sterilization and lab testing.
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Senior Clinical Research Associate VeranexDeutschland 3mo Senior Clinical Research Associate supporting innovative medical device studies across Germany and potentially throughout Europe.
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HCLTech WalkIn Medical/Life science in Chennai on 30th May HCLTechChennai, Tamil Nadu 3mo Managing global complaint trends and post-market surveillance for medical devices to ensure regulatory compliance and product safety.
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Investigation Engineer - Medical Devices↗ BdWinnersh, England, UK $33k–$33k4mo Investigate customer complaints related to medical devices, perform root cause analysis, and ensure timely resolution in line with regulatory and quality standards.
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Regulatory Affairs Specialist ElektaVeenendaal 4mo Enable market access for regulated medical devices by preparing submissions, responding to agency actions, and ensuring compliance.
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Sr. Manager, Medical Device Cyber Security TempusChicago $150k–$150k4mo Own the medical device cyber security program, acting as a bridge between enterprise security strategy and product-level technical execution for Tempus Medical Devices.
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Vice President, MedTech Cardiovascular Regulatory Affairs IqviaWashington, DC, United States of America $169k–$169k4mo Leading regulatory strategy and submissions for medical device and diagnostics clients, managing department operations, and acting as a primary contact for regulatory bodies.
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Engineering Director Medical Device UromemsAuvergne-Rhône-Alpes, France 4mo Lead engineering organization in design, development, and delivery of innovative medical technologies aligned with regulatory standards.
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Regulatory Affairs Manager - Medical Device Meditrial Europe Ltd.Roma, Provincia di Roma 4mo Oversees the regulatory process for medical devices and marketing authorizations, managing government interactions, inspections, and compliance strategies.
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Design Assurance Engineer, Device Technical Operations ( 18 Months FTC ) ViatrisNorthern Cross, Dublin, Ireland 4mo Provide Design Assurance oversight for the creation, maintenance, and transfer of technical documentation and manufacturing processes for medical devices and combination products.
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Chargé d'Affaires Radioprotection et Contrôle des dispositifs Médicaux H/F SocotecLyon, Auvergne-Rhône-Alpes, fr $36k–$45k4mo Regulatory inspection and quality control for medical devices and radiation protection in the healthcare and industrial sectors.
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Senior Consultant - MedTech Regulatory Implementation VeevaRemote $80k–$80k5mo Lead MedTech Regulatory Information Management (RIM) implementations, guiding the transformation of customers' Regulatory Affairs and Operations processes through Veeva's industry cloud technology.
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Medical Device Regulatory and Quality Consultant Pa-ConsultingMelbourn, gb 5mo Consultant advising clients on regulatory, quality, and compliance aspects of medical devices, SaMD, and combination products.
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Biocompatibility Program Manager MarmonHillsboro, OR, US 5mo Establishing and directing the biocompatibility program to ensure patient safety and regulatory compliance for medical device products.
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MDR Compliance Associate Tandem HealthStockholm 5mo Maintain and organize technical documentation for AI-powered software as a medical device (SaMD) to ensure compliance with EU MDR regulations.
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