Regulatory Affairs
404 open positions
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EU Post Market Surveillance Specialist IntuitiveMadrid, SPAIN, es today Evaluates medical device complaints, determines vigilance reporting requirements, and conducts follow-up investigations to support regulatory compliance.
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Segment Manager Medical Devices Benelux SgsSpijkenisse, ZH, nl today Develop and execute the Medical Devices growth strategy for Benelux, owning the segment P&L, revenue growth, and profitability.
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Director, Regional Device & Drug Delivery Center of Excellence (RTC) PciservicesStamullen, Co. Meath, IRL, IE 1d Lead the design, assembly, validation, and regulatory strategy for drug delivery devices (autoinjectors, pens) and container closure systems for biopharma clients.
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Principal I, Microbiology & Toxicology AlconFort Worth, Texas, US 1d Scientific leader responsible for biological safety evaluation, risk-based biocompatibility strategies, and toxicological risk assessments for medical devices and combination products.
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Regulatory Affairs Manager AbbottAustralia - New South Wales - Eastwood 1d Lead regulatory compliance activities for Abbott's Rapid Diagnostics division across Australia, New Zealand, and Pacific Islands, ensuring market access for medical devices and diagnostics.
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Staff Regulatory Specialist- Post Market Intelligence StrykerGurugram, India 1d Assess adverse events and post-market information for medical devices to ensure compliance with global regulatory requirements and identify safety signals.
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Associate Regulatory Affairs Systems Specialist MedtronicTaguig City, National Capital Region, Philippines 1d Manage regulatory systems, submission workflows, and documentation tracking to support product registration and compliance across Southeast Asia.
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Senior Consultant – CRA & AI Act Pharma & MedTech Knightec Group Compliance and Management ABGöteborg, Sweden 2d Lead GAP analyses and support customers in classifying AI systems and connected medical devices against the EU Cyber Resilience Act (CRA) and AI Act.
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Regulatory Affairs Analyst (Temporary position) (Based in Ciudad de Mexico) EdwardsMexico-Mexico City 2d Completes and maintains regulatory approvals and clearances for medical devices, prepares domestic and international product submissions, and develops routine process improvement initiatives.
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Associate Director, Safety Management↗ Rqm+Remote 2d Lead safety and medical affairs oversight for medical device clinical studies, ensuring compliance with regulations and managing safety data trends.
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Medical Devices Auditor - Organics. German speaking (m/f/x)↗ BsiDE $74k–$90k2d Conduct on-site, remote, or hybrid audits of medical device quality management systems to ensure regulatory compliance and patient safety.
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Regulatory Affairs Engineer, Post-Market Surveillance Neko-HealthStockholm 2d Operate and improve the post-market surveillance (PMS) system across the medical device portfolio, ensuring consistent application of PMS SOPs and generating periodic reports for Notified Bodies.
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Director, Combination Products & Device Development AbCelleraVancouver $200k–$200k2d Architect device platform strategy and oversee design controls to advance drug-device combination products (prefilled syringes, autoinjectors) through commercial launch.
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Chef principal, Affaires réglementaires AbbVieMontreal, QC, ca 2d Leading and supervising a regulatory affairs team to support the submission and approval of regulatory submissions to Health Canada for AbbVie's developing and marketed products, including medical devices.
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Associate Director Science & Technology (m/f/d) NovartisSchaftenau, AT $88k–$88k3d Lead the creation of analytical data packages for drug-device combination products, specifically injectables like biologics and radio-ligands in autoinjectors or needle-safety devices.
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R&D Engineering Associate (Co-op)↗ Boston ScientificMississauga, ON, CA $34k–$34k3d Assist in the ideation, design, prototyping, and manufacturing transfer of cutting-edge medical devices, including verification testing, regulatory filings, and clinical trial support.
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QA/RA Engineer – Medical Devices↗ Emtensor GMBHWien, W, AT 3d Implementing Quality Management Systems and technical documentation for a new brain imaging medical device to support stroke and traumatic brain injury diagnosis.
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Sr. Principal of Industrial & Medical Product Design↗ Stress Engineering Services IncMason, OH, US 3d Lead multidisciplinary teams to guide clients through the complexities of medical device development, commercialization, and regulatory submission for surgical devices, drug delivery systems, and diagnostics.
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Spécialiste des affaires réglementaires | Regulatory Affairs Specialist↗ I-Med Pharma Inc.Saint-Laurent, QC, CA 3d Supports execution and maintenance of regulatory activities for medical devices, cosmetics, nutraceuticals, and veterinary products.
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MEDICAL AFFAIRS MANAGER (M/F/D)↗ GetingeRemote 3d Clinical and scientific expert for cardiovascular/vascular surgical devices, bridging clinical practice with medical technology lifecycle management.
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Medical Device Development Specialist EurofinsCambridge, England, gb 3d Lead multidisciplinary medical device development projects for drug delivery devices, managing the full lifecycle from concept to industrialisation.
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Regulatory Affairs Manager/Senior Manager – CMC & Regulatory Change Management - FSP ThermofisherRemote, Switzerland 4d Client-dedicated Regulatory Affairs Manager assessing EU/EEA regulatory impact of CMC, manufacturing, supply, and labelling changes for clinical trial medicinal products.
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Senior Regulatory Affairs Specialist (Hybrid - Acton, MA) InsuletActon, Massachusetts, US $92k–$92k4d Lead regulatory affairs activities to support domestic and international registration and submissions for medical devices.
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Design Assurance Engineer 2↗ HologicMarlborough, MA, US $78k–$78k4d Provide design assurance support for new product development and on-market medical devices by ensuring design controls, verification, validation, risk management, and regulatory compliance are effectively implemented.
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Director, Regulatory Affairs ElementbiosciencesSan Diego - Headquarters $152k–$152k4d Build and lead global regulatory strategy for in vitro diagnostic (IVD), next generation sequencing (NGS), and regulated life science instrumentation products to support market authorization and commercial expansion.
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Manager Regulatory Affairs (m/f/d) NovantaBerlin, Germany 5d Manage regulatory submissions and approvals for medical devices to ensure timely market placement and compliance throughout the product lifecycle.
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Regulatory Scientist, Vascular↗ Cook GroupRemote 5d Develop and implement scientifically sound regulatory strategies for premarket and post-market medical device submissions, ensuring compliance with global regulatory requirements.
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Senior Software Design Quality Engineer (Medical Devices SaMD)↗ Systems AllyCarlsbad, CA, US $83k–$83k6d Senior Software Quality Engineer ensuring compliance and lifecycle management of regulated medical device software (SaMD, embedded, connected, wearable) through design controls, risk management, and verification/validation.
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Project Manager↗ True Diagnostics Inc.Remote $135k–$135k7d Lead end-to-end project execution for new product introductions, transfers, or design updates in a medical device contract manufacturing environment, ensuring compliance with regulatory requirements.
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Product Operations and Support Specialist JobgetherRemote 7d Tier 2 escalation point for an integrated hardware-software medical device used in live clinical environments, handling technical troubleshooting, complaint handling, and product operations.
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RAQA Associate ZeissgroupSeoul 8d Supports Regulatory Affairs and Quality Assurance functions for medical device product registrations and quality compliance.
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Project Manager, Service & Repair JjDanvers, Massachusetts, United States of America $79k–$79k8d Lead cross-functional projects to support and enhance service & repair operations, ensuring safety, regulatory compliance, and operational excellence for medical devices.
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