Regulatory Affairs
747 open positions
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Junior Specialist CQA (m/w/d) BaxterWien, Vienna, AT 23d Supporting local documentation, field actions, and regulatory submissions for Baxter products in the DACH region.
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Product Surveillance Analyst↗ VivaPlymouth, MN, US 23d Inspect, test, and evaluate returned medical devices to support post-market surveillance and product complaint investigations.
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Product Complaint Investigator III (Temporary 1 year) BostonscientificPropark Free Zone, Coyol de Alajuela, Costa Rica | Costa Rica-Coyol 23d Execute complex product complaint investigations ensuring regulatory compliance and operational excellence in a regulated medical device environment.
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CE-Koordinator (m/w/d) Heuft Systemtechnik GmbHBurgbrohl, RHEINLAND_PFALZ 23d Ensures CE compliance and product safety for HEUFT's machines, devices, and IT products in the food, beverage, and pharmaceutical industries.
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Jurist/in MED-EL Elektromedizinische Geräte GmbHHötting, TIROL 23d Ensuring products comply with regulations and standards by providing strategic input for product development, obtaining and maintaining product registrations and approvals, communicating with authorities, and monitoring regulatory changes.
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Senior Manager Medical Device Safety & Post-Market Surveillance ZeissgroupLisboa, PT 23d Lead global execution, governance, and continuous improvement of the Post-Market Surveillance (PMS) system for medical devices, ensuring compliance with regulations like EU MDR and FDA.
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Supervisor, Reg Affairs CardinalhealthUS-Nationwide-FIELD $80k–$117k23d Supervises regulatory programs, policies, and procedures for human drug, medical device, and cosmetic portfolios to ensure commercial and post-market compliance.
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Senior Regulatory Labeling Specialist HeartflowincRohnert Park $145k–$168k23d Authoring and maintaining Instructions for Use (IFU) and product labeling, and reviewing marketing materials for regulatory compliance in the medical device industry.
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Regulatory Affairs Leader - Asia 3mcompanySingapore 23d Provide strategic regional leadership for regulatory strategies supporting new and marketed medical device products across the Asia-Pacific region.
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Senior Manager, Regulatory Affairs IntuitiveSunnyvale, CA, us 23d Lead global regulatory strategy and execution for software-driven medical products, including SaMD, SiMD, cloud applications, and AI/ML-enabled features supporting surgical care.
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Regulatory Affairs Leader - Asia SolventumSingapore 24d Provide strategic regional leadership for regulatory strategies supporting new and marketed medical device products across the Asia-Pacific region.
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Senior Development Engineer↗ Riverpoint MedicalPortland, OR, US 24d Develop products, processes, and test methods to create superior surgical solutions, transforming medical device concepts from ideas through verification and validation to market launch.
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Regulatory Specialist MedlineChateaubriant, FR 24d Ensure CE marking compliance for medical devices sold/distributed by Medline in the European market and manage post-market surveillance systems.
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European Product Safety & Compliance Specialist↗ Midea GroupZaragoza, Aragon, Spain 24d Ensure product safety and regulatory compliance for Midea's microwave and oven portfolio across the European market through testing, quality control, and design guidance.
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VP, Regulatory Affairs & Quality Assurance↗ Blackrock NeurotechRemote 24d Strategic and operational leadership for Regulatory Affairs and Quality Assurance to support the development, clinical advancement, regulatory approval, and commercialization of next-generation neurotechnology and implantable brain-computer interface products.
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Manufacturing Engineer↗ Katalyst Healthcares & Life SciencesWest Lancaster, PA, US 24d Lead technical Life Cycle Management (LCM) projects for orthopedic medical devices, specifically metal implants, managing external manufacturing partners and ensuring regulatory compliance.
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Product Quality Manager, Medical Devices GaldermaBarcelona, ES 24d Ensure quality and regulatory compliance for a portfolio of medical devices and combination products across the entire lifecycle.
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Sustaining Project Engineer, Robotics SmithnephewPittsburgh, PA, US 24d Technical lead for sustaining and global registration projects for the CORI Surgical System, focusing on engineering analysis, design, testing, and regulatory compliance.
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QA & RA Officer Nico.LAB International LimitedRemote 24d Ensuring Nicolab's quality management system and product registrations comply with international medical device regulations (ISO 13485, EU MDR, FDA QMSR) to enable safe AI-powered stroke imaging software deployment.
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Quality & Regulatory Assistant Manager EssilorLuxotticaSingapore 24d Own product quality and regulatory compliance for ophthalmic lens products across APAC, covering new product introduction, customer complaints, and product registrations.
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QA & RA Officer↗ NicolabMelbourne, VIC, AU 25d Ensure quality management system compliance with international standards (ISO 13485, EU MDR, FDA QMSR) and manage product registrations for AI-powered stroke imaging software.
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R&D Engineer (Systems Engineer) - Medical device↗ Systems AllySan Diego, CA, US $104k–$166k26d Lead systems engineering for complex, regulated medical devices including infusion pumps and drug delivery systems from user needs through architecture, risk management, verification & validation, and launch.
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Senior Medical Device Regulatory Policy Lead
GoogleBangalore, Karnataka
26d
Drive Google's advocacy in India for medical device features, specifically digital health, healthcare AI, and Software as a Medical Device (SaMD), by facilitating executive-level agency relationships and representing technical positions in industry coalitions.
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Quality Manager II, Combination Products & Medical (all genders) (fulltime, regular) AbbVieLudwigshafen, RP, de 26d Ensure compliance with worldwide Combination Product and Medical Device Regulations for products developed, manufactured, tested, and procured.
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Sr. RA Engineer ThermofisherGuangdong, China 27d Ensures regulatory compliance for Thermo Fisher China manufactured medical devices against China and overseas requirements.
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健康医学硬件工程师 HuaweiXi'an, China 27d End-to-end management of clinical trials and regulatory certification for medical hardware products.
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Device Manager (Cell Therapy Combination Product)↗ Neurona TherapeuticsSouth San Francisco, CA, US 27d End-to-end technical and operational leadership for the evaluation, selection, development, qualification, clinical implementation, and commercialization of devices used in the preparation and delivery of cell therapies.
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Lead R&D Engineer↗ Hollister IncorporatedLibertyville, IL, US $115k–$155k27d Senior individual contributor leading the identification, design, development, and commercialization of medical devices from concept through prototype and validation.
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Fremdsprachenkorrespondent/in (m/w/d) MDSS GmbHHannover, NIEDERSACHSEN 27d Managing multilingual correspondence and administrative tasks for medical device regulatory affairs, ensuring smooth information flow between clients, authorities, and internal teams.
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Director of Customer Support ZollAtlanta, GA, US $105k27d Lead a 24/7 technical customer support department for patients, clinicians, and sales reps, managing call center operations, troubleshooting medical device issues, and ensuring regulatory compliance.
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Manager Combination Products - Regulatory Affairs RegeneronRENSSELAER, US $108k–$176k27d Support global combination product development, regulatory submissions, and post-market activities for life-changing medicines.
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Senior Staff R&D Engineer - Systems StrykerWaltham, Massachusetts, US $123k–$205k27d Provide system-level technical leadership for medical devices throughout the lifecycle, focusing on commercialization, sustaining engineering, and resolving complex product issues.
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Entry Level Engineer↗ Bridgemed SolutionsIrvine, CA, US 27d Support senior engineers in medical device manufacturing, specifically tissue heart valve technology, ensuring alignment with regulatory requirements.
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Global Regulatory Packaging Compliance Leader GE HealthCareBangalore, Karnataka 27d Establish and lead global packaging regulatory compliance frameworks, monitor emerging regulations (EU PPWR, EPR), and translate complex requirements into actionable technical and business strategies for GE HealthCare medical devices.
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Chargé d’Affaires Réglementaires F/H ClinactMontfort-l'Amaury, Rambouillet 27d Prepare, submit, and track regulatory dossiers for clinical studies involving medicines and medical devices in France and internationally.
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Quality & Regulatory Affairs (m/w/d) Medizintechnik Geratherm Respiratory GmbHBad Kissingen, BAYERN 28d Head of Quality & Regulatory Affairs responsible for developing and maintaining the QMS and ensuring regulatory compliance for medical devices and software.
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Medical Device Quality Assurance & Regulatory Affairs Specialist↗ Nordicinfu Care ABBromma, Stockholm County, Sweden 28d Ensures Nordic Infucare complies with Nordic and EU regulations for medical device distributors, manages the Quality Management System (QMS), and acts as the primary regulatory liaison.
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ONLY Biomedical Engineer. NO RESEARCH TECH NEEDED AT THIS TIME.↗ Biomed CompanySanta Clara, CA, US $73k28d Design, develop, and optimize medical devices and diagnostic tools using biotechnology, mechanical engineering, and molecular biology expertise.
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Risk Manager Medical Device (m/w/d)↗ HeraeusWehrheim, HE, DE 28d Manage risk across the complete product lifecycle for medical devices, ensuring compliance with regulations and standards.
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Post Market Complaint Data Analyst↗ Advita OrthoGainesville, FL, US 28d Analyze and manage post-market complaint data to ensure medical device safety and efficacy, supporting root cause analysis and corrective actions.
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Regulatory Affairs Manager PhilipsShenzhen, CN 28d Guide the business through the regulatory landscape for class I and class II medical device and non-medical consumer product groups, ensuring compliance with external regulations and company policies.
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