We are looking for a Principal Consultant in Medical Devices Regulatory Affairs and Quality to join our team in Paris. You will lead international regulatory and quality projects, advise clients on market-access strategies, and provide technical expertise across medical devices, IVDs, software, and AI-enabled medical devices.ResponsibilitiesDevelop and propose regulatory strategies for Europe, the United States, and other international marketsLead regulatory projects, including CE marking, FDA 510(k) submissions, and international registrationsPrepare, review, and maintain technical documentationSupport risk management and risk-analysis activitiesAdvise a wide range of clients, from start-ups to large international organizationsSupport remediation activities and interactions with Notified BodiesProvide regulatory expertise for software medical devices, SaMD, and AI-enabled medical devicesSupport the compliance of electromedical devices with applicable IEC 60601 requirementsConduct Quality Management System audits in accordance with ISO 13485Support MDSAP audits and readiness assessmentsPerform regulatory and quality due diligence for acquisitions, investments, licensing agreements, and strategic partnershipsIdentify compliance gaps, assess associated risks, and define remediation plansManage client projects and contribute to business-development activitiesCoordinate and supervise consultants, depending on experienceContribute to the development of internal regulatory expertise and best practicesExperienceMaster's degree or equivalent, ideally in engineering, pharmacy, biomedical engineering, quality, regulatory affairs, or another scientific or technical disciplineAt least 8 years of experience in the medical device and/or IVD industryStrong knowledge of EU MDR 2017/745 and/or EU IVDR 2017/746Very good knowledge of IEC 62304 and medical device software lifecycle requirementsExperience with software medical devices and/or AI-enabled medical devicesExperience preparing and reviewing technical documentation for CE markingExperience with international regulatory submissions, particularly in the United States, would be a strong advantageKnowledge of electromedical devices and the IEC 60601 series would be highly valuedExperience with ISO 13485 audits and MDSAP would be an advantageProfessional proficiency in EnglishFluency in French or Italian

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Principal Consultant, Medical Devices Regulatory & Quality