Regulatory Affairs
747 open positions
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Sr Biocomptibility Specialist ConvaTecUK - Greater Manchester 20d Execute biocompatibility projects for New Product Development and Life Cycle Management, designing technical approaches for biological evaluations and analyzing data to ensure device safety.
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Assoc Director, Regulatory Affairs CMC GileadUnited States - California - Foster City $182k–$236k20d Define and advance global CMC regulatory strategy for combination products and devices, ensuring regulatory integration into development and lifecycle planning.
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Head of Global Medical Device Safety & Post-Market Surveillance↗ ZEISS GroupLisboa, P11, PT 20d Lead global strategy, governance, and compliance for Medical Device Safety, Vigilance, and Post-Market Surveillance (PMS) to ensure patient safety and regulatory adherence across international markets.
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Principal Engineer, S/W QA Cyber Security↗ Boston ScientificHR, IN 20d Senior individual contributor providing independent Quality oversight and technical leadership for product cybersecurity activities across the medical-device product lifecycle.
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Quality & Regulatory Affairs Manager↗ HeimLondon, ENG, GB £60k20d Own the quality management system and regulatory route to market for AI-native software medical devices (SaMD) to ensure compliance with UKCA Class I and II, ISO 13485, and UK GDPR.
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Design Assurance Engineer↗ Valtera Group LtdDublin, County Dublin, Ireland 20d Own design control and risk management for a portfolio of drug delivery devices from concept to approval.
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R&D Advanced Therapeutics Manager- Relocation Assistance Provided↗ Innovative HealthScottsdale, AZ, US 20d Leading the development of advanced medical device reprocessing platforms, including Class III devices and complex electromechanical systems, with a focus on system-level architecture, reverse engineering, and validation of functional equivalence.
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Sr. R&D Engineer- EP↗ AbbottSaint Paul, MN, US $78k–$156k20d Sr. R&D Engineer leading product development for diagnostic, imaging, and ablation therapy catheters and EP capital equipment in the medical device industry.
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Senior Engineer↗ Tidi Products, LLCNeenah, WI, US $98k–$113k20d Leading engineering projects for cost improvement and sustaining engineering of medical device products, focusing on design changes, manufacturing efficiency, and regulatory compliance.
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Customer Advocacy Generalist DexcomVilnius, Lithuania €19k–€24k20d Review and evaluate customer complaint documentation, maintain records of investigations, and write Manufacturer Incident Reports for a medical device company.
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Regulatory Affairs Strategist, Globalization (eIFU/ Est. Registrations) BdxUSA NJ - Franklin Lakes 20d Strategic partner enabling aligned execution of global regulatory affairs strategies, processes, and best practices for labeling, eIFU, establishment registrations, and device listings across Business Units and Regions.
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Global Product Security Manager (Medical) DanaherSGP - Singapore - Leica Microsystems 20d Partner with medical product development teams to integrate cybersecurity and privacy requirements throughout the product lifecycle, ensuring compliance with industry standards and regulatory expectations.
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Product Compliance Manager (m/w/d) INOTEC Sicherheitstechnik GmbHRemote 20d Advises development, quality assurance, and product management on regulatory and normative requirements for emergency lighting products; maintains factory standards and product files; supports certification projects and market expansion.
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Product Engineer II (m/w/d) - Sustaining Engineering Jotec GmbHHechingen, BADEN_WUERTTEMBERG 20d Sustaining Engineer responsible for the post-market lifecycle of marketed medical devices, ensuring safety, quality, manufacturability, and regulatory compliance.
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Senior Compliance Manager – Quality & Regulatory Affairs / QMB ISO 13485 (m/w/d) Vivira Health Lab GmbHBerlin / Berlin Hybrid 20d Senior Compliance Manager responsible for Quality Management System (QMS) and regulatory compliance for medical devices and digital health apps.
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Manager, Combination Products and Medical Devices (all genders) (fulltime, regular) AbbVieLudwigshafen, RP, de 20d Represent QA on cross-functional combination product and medical device development teams to ensure compliance with worldwide regulations.
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Clinical Assessor DnvSingapore 20d Review and assess Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), and supporting clinical evidence to evaluate the adequacy, scientific validity, relevance, and consistency of clinical data supporting device safety, performance, and…
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Product Information / Labeling Subject Matter Expert (SME) - Medical Devices NTT America, Inc.Bangalore, Karnataka 20d Lead global product labeling, Instructions for Use (IFU), packaging, and regulatory documentation for medical devices to ensure compliance and accuracy across markets.
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Regulatory Affairs Manager M/F/X (CDI) NemeraLyon, Auvergne-Rhône-Alpes, fr 20d Lead Regulatory & Compliance activities for ENTD, Ophthalmic, and Inhalation medical devices and combination products across the full product lifecycle.
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Senior Design Verification Engineer↗ Laborie Medical TechnologiesPortsmouth, NH, US 21d Leading lifecycle management and sustaining engineering for capital medical equipment in Urology and Gastrointestinal product lines, ensuring safety, performance, and regulatory compliance.
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Design Engineer, Oral Care Category↗ DysonSG 21d Design and develop Oral Care products from concept through production within a regulated medical device framework.
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Senior Compliance Manager – Quality & Regulatory Affairs / QMB ISO 13485 (m/w/d)↗ Vivira Health LabBerlin, BE, DE 21d Senior Compliance Manager responsible for Quality Management System (QMS) and regulatory compliance for medical devices and digital health apps.
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QM Associate – Product Registrations (part-time 20h/week)↗ BrainlabMünchen, BY, DE 21d Manage worldwide registration of medical devices by preparing regulatory submissions to health authorities and monitoring international regulations.
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Becario de Calidad↗ VescicaSan Diego Ocoyoacac, DIF, MX $48k21d Intern role supporting regulatory filings, quality control documentation, and packaging verification for medical aesthetic devices.
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Senior Manager, Regulatory Affairs - Medical Device↗ PharmalexMadrid, Community of Madrid, Spain 21d Lead project delivery and provide expert regulatory consultancy for medical device, diagnostics, and drug-device combination product clients.
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Senior Project Lead MarmonKarnataka, IN 21d Lead dedicated engineering teams for Marmon Medical Group companies, managing projects across New Product Development, Continuous Engineering, and Value Analysis to deliver compliant medical device solutions.
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Associate II, Software Engineering AlconBangalore, India 21d Plan and coordinate software documentation changes, maintain electronic repositories, and support audit/regulatory compliance for medical device software.
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Clinical Scientist Intern IntuitiveSunnyvale, CA, us 21d Intern supporting the development of Clinical Evaluation Reports (CER) and regulatory documents for EU CE Mark applications, including literature reviews and clinical data summaries.
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Senior Consultant – CRA & AI Act Pharma & MedTech Knightec Group Compliance and Management ABGöteborg, Sweden 21d Lead and execute GAP analyses against CRA and AI Act for connected medical devices and digital pharmaceutical solutions; support customers in classifying AI systems under the AI Act; develop and review regulatory, risk, and cybersecurity processes throughout…
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Regulatory Operations Manager (m/w/d)↗ HeraeusWehrheim, HE, DE 22d Coordinate global regulatory registration processes, SOPs, and cross-functional workflows for medical device approvals and product status.
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Regulatory Affairs Manager↗ Stratum Talent SearchMadrid, MD, ES 22d Ensuring pharmaceutical, biotech, or medical device products comply with local and international regulations throughout their lifecycle.
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Senior Design Quality Engineer, New Product Development Advanced StrykerFlower Mound, Texas, US $86k–$143k22d Senior Design Quality Engineer ensuring surgical device quality from concept to commercialization, driving patient safety and surgical efficiency.
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Regulatory Affairs Manager MedtronicNorth Haven, Connecticut, United States of America 22d Establish strategies for worldwide product approval and submission activities, directly executing submissions focused on the U.S. and EU, and ensuring regulatory compliance for products within the Surgical Operating Unit.
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Sr Program Manager, EU MDR PhilipsMurrysville, Pennsylvania, United States $121k–$193k22d Lead EU MDR compliance initiatives and remediation projects for the Sleep & Respiratory Care team, ensuring regulatory milestones are delivered on time and within budget.
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Principal Laboratory Engineer GehcWaukesha, US 23d Provide technical leadership for global mechanical and environmental laboratory capabilities to support medical device product certification, testing strategies, and design validation.
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?Regulatory Affairs Manager (contract)↗ Outram, S00, SG 23d Lead regulatory, medical affairs, and quality activities to ensure compliance for therapeutic products, traditional medicines, cosmetics, and food in Singapore and Brunei.
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Engineering Test Lab Manager↗ Si-BoneSan Jose, CA, US $132k–$148k23d Operational oversight of mechanical testing lab activities for medical device development, including planning, execution, and documentation of static and dynamic testing.
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