Regulatory Affairs
750 open positions
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Senior Manager, Global Device Quality↗ ViatrisDublin, County Dublin, Ireland 4mo Provide global leadership to establish, maintain, and implement Viatris' Global Quality Standards for medical devices and combination products, ensuring compliance with global regulatory requirements.
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Senior Regulatory Affairs Specialist, APAC ZollSelangor, Malaysia 4mo Preparing regulatory submissions and maintaining compliance for new or modified medical devices in domestic and international markets.
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Regulatory, Quality & Compliance Lead (m/w/d) ocumeda GmbHMünchen 4mo Lead Regulatory, Quality, and Information Security functions for a growing SaMD company, driving regulatory maturity and translating complex requirements into pragmatic business decisions.
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Ärztliche Unterstützung / Medical Advisor (m/w/d) Ecovery GmbhLeipzig / Remote (in Deutschland) 4mo Provides medical expertise to support Clinical Operations and Therapy in planning, conducting, evaluating, and documenting clinical studies, as well as addressing medical-regulatory questions for medical devices and DiGA.
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Global Technical Manager – Sterilization SgsRemote 4mo 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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QMB (m/w/d) für unser Qualitätsmanagement (ISO 13485) in Kombination mit Regulatory Affairs Aufg gbo Medizintechnik AGRimbach, Odenwald, HESSEN 4mo Maintaining and developing the ISO 13485 quality management system and handling regulatory affairs tasks for medical device development and production.
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Project Manager PhilipsShenyang 4mo Lead cross-functional teams to achieve system program objectives in the medical device industry.
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Assistant Manager - Clinical - Chennai/Cochi↗ Fresenius Medical CareChennai, Tamil Nadu, India 4mo Planning, executing, and overseeing clinical activities, post-market surveillance, and evidence generation for medical devices and therapies to ensure regulatory compliance and support market adoption.
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Regional Regulatory Affairs Lead, US Neko-HealthNew York 4mo Build the US regulatory affairs function from the ground up, manage FDA relationships and submissions, and hold statutory roles for US market entry.
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Tender & Contract Coordinator- Italy MeritItaly - Virtual 4mo Monitor and analyse tender alerts, prepare and submit compliant tender applications, and manage contract awards for medical device products.
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Associate Director, Regulatory Legal Counsel IlluminaEngland - Cambridge £111k–£166k4mo Provide strategic legal advice on regulatory requirements for medical devices, diagnostics, and life science products across EMEA and Latin America.
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Technical Specialist - Active Medical Devices↗ BsiRemote £59k5mo Review and evaluate medical device technical and clinical documentation to assess compliance with European and UK medical device regulations, managing certification activities for manufacturers.
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Systems & Requirements Engineer (w/m/d) – Medizintechnik RAYDIAX GmbHMagdeburg 5mo Translating regulatory requirements into design inputs and managing the requirements lifecycle for a medical device product.
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🧪 Toxikologe/in (m/w/d) im Bereich Regulatory Toxicology, Medical Writing & Beratung Iason consulting GmbH & Co. KGNiederzier, NORDRHEIN_WESTFALEN 5mo Conduct regulatory toxicology assessments, derive health-based limits (PDE, ADE, TTC), and evaluate biological safety for medical devices and pharmaceuticals.
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Regulatory Affairs Senior Specialist - Supply Chain Projects ResmedSingapore, Singapore 5mo 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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Produktexpert*in In-vitro-Diagnostika (w/m/d) / 17297 AMD TÜV Arbeitsmedizinische Di enste GmbH TÜV Rheinland GroupKöln, NORDRHEIN_WESTFALEN 5mo Evaluate technical documentation and test results for In-vitro-Diagnostic (IVD) products to ensure compliance with EU regulations (IVDR) and international standards.
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Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors TakedaBoston, MA $212k–$333k5mo 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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EAS Gas Director SoterahealthRemote 5mo Lead gas-related Expert Advisory Services (EAS) projects, ensuring technical execution, customer experience, and alignment with industry/regulatory standards.
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Product Reviewer (IVD – Companion Diagnostics) (w/m/d) TÜV SÜD AGMünchen, BAYERN 5mo Senior subject matter expert for Companion Diagnostics (CDx) performing IVDR conformity assessments, regulatory strategy, and technical documentation reviews for CDx devices and their associated medicinal products.
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Risikomanager Medizintechnik (m/w/d) Löwenstein Med.Techn.GmbH+Co.KGHamburg, HAMBURG 5mo Application and responsibility of the Safety Risk Management process according to ISO 14971 for medical devices in the Patient Interfaces area.
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Vice President, MedTech Cardiovascular Regulatory Affairs IqviaWashington, DC, United States of America $169k5mo 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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Specialist Product Certification Sportproducts (m/w/d) UVEX SAFETY GROUP GmbHFürth, Bayern, BAYERN 5mo Responsible for product certifications according to the PPE Regulation (EU) 2016/425 for the sports product portfolio, ensuring legal market entry and product safety.
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Ingenieur als Technischer Produktverantwortlicher (m/w/d) Medizintechnik Löwenstein Medical SE & Co. KGRemote 5mo Managing product changes across the entire lifecycle in compliance with medical device regulations and standards.
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Verwaltungskraft (m/w/d) für die Medizintechnik Universitätsklinikum UlmDeutschland 6mo Administrative and technical management of medical devices, including inventory, repair coordination, and regulatory compliance.
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Product Conformity Specialist (m/w/d) Raith GmbHGermany, Dortmund 6mo Ensuring CE conformity for maskless nanofabrication systems and structuring processes according to EU machinery regulations and ISO standards.
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Chargé d'Affaires Radioprotection et Contrôle des dispositifs Médicaux H/F SocotecLyon, Auvergne-Rhône-Alpes, fr €36k–€45k6mo Regulatory inspection and quality control for medical devices and radiation protection in the healthcare and industrial sectors.
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Associate Director, Aesthetics Clinical Development AbbVieIrvine, CA, us 6mo Leads the design, development, evaluation, planning, and execution of clinical studies for novel medical devices in Aesthetics, ensuring scientific integrity and regulatory compliance.
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Regulatory Affairs Manager M/F/X (CDI) NemeraRemote 8mo Lead Regulatory & Compliance activities for ENTD, Ophthalmic, and Inhalation medical devices and combination products, managing the regulatory team and supporting customers in notification procedures across EU, US, and Canada.
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Projektmanager Vertrieb und Projektmanagement (m/w/d) Eurofins Inpac Medizintechnik GmbHBirkenfeld, Württemberg, BADEN_WUERTTEMBERG 8mo Managing new packaging and development projects in the medical device sector, from initial calculation and quoting to customer support and implementation.
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Beauftragter für Medizinproduktesicherheit Gesamthaus (w/m/d) Wohnstift Rathsberg e. V.Erlangen, BAYERN 9mo Central point of contact for medical device user consultation, handling special incidents, and ensuring compliance with reporting obligations.
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Vi söker Seniora QA/RA Medtechkonsulter PrevasSundbyberg, SE 12mo Senior consultant providing regulatory and quality assurance support for medical device and in-vitro diagnostic product development, focusing on strategy, documentation, and compliance.
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APAC Regulatory Policy Lead - Medical Devices AppleBeijing, China 1y Lead Apple's medical device policy advocacy and regulatory strategy across the APAC region to accelerate access for health features.
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Compliance Specialist 2 IntuitiveTokyo, JAPAN, jp 1y Ensures timely post-marketing safety filings (GVP) and complaint handling documentation for medical devices, communicating with Japanese regulatory agencies.
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Esperto per Certificazione dispositivi medici EurofinsTurin, Piedmont, it 1y Expert in medical device certification and regulatory compliance, performing technical file analysis and on-site audits for manufacturers and notified bodies.
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Direktvermittlung: (Senior) Specialist (m/w/d) Regulatory Affairs hebUP GmbHMünchen, BAYERN 1y Creating and maintaining technical files for medical devices, acting as the liaison for regulatory authorities, and managing global regulatory changes for a surgical laser company.
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ODM PM - Medical Equipment (Embedded ACG/ 林口園區) AdvanTechLinkou 2y Program/Product/Project Manager for Medical Equipment embedded systems within Design and Manufacturing Services, driving product lifecycle from conceptualization to manufacturing.
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Mechanical Engineer R&D Medical Devices (m/f/d)↗ X-Therma GMBHRemote 55k2y Technical leadership for medical device development projects from ideation to production, ensuring regulatory compliance and quality.
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Regulatory Engineer NeuralinkAustin $71k–$119k Enable global access to Neuralink's technology by managing regulatory affairs, clinical evaluations, and market introduction for medical devices.
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Clinical Engineering Cyber Specialist SkyeliaWoodmere, NY Leading the implementation of cybersecurity controls, risk assessments, and vulnerability remediation for medical devices in a hospital setting.
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Leader: Indication Prioritization and Clinical & Regulatory Strategy (Nano-Electronic Neural Implants) Cahira TechnologiesBoston, MA Lead the human-translation roadmap and indication-prioritization process for a wireless nano-electronic neural implant platform, spanning late pre-clinical work through global regulatory approvals and commercial launch.
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