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.

Responsibilities:

  • Develop and propose regulatory strategies for Europe, the United States, and other international markets
  • Lead regulatory projects, including CE marking, FDA 510(k) submissions, and international registrations
  • Prepare, review, and maintain technical documentation
  • Support risk management and risk-analysis activities
  • Advise a wide range of clients, from start-ups to large international organizations
  • Support remediation activities and interactions with Notified Bodies
  • Provide regulatory expertise for software medical devices, SaMD, and AI-enabled medical devices
  • Support the compliance of electromedical devices with applicable IEC 60601 requirements
  • Conduct Quality Management System audits in accordance with ISO 13485
  • Support MDSAP audits and readiness assessments
  • Perform regulatory and quality due diligence for acquisitions, investments, licensing agreements, and strategic partnerships
  • Identify compliance gaps, assess associated risks, and define remediation plans
  • Manage client projects and contribute to business-development activities
  • Coordinate and supervise consultants, depending on experience
  • Contribute to the development of internal regulatory expertise and best practices

Experience

  • Master’s degree or equivalent, ideally in engineering, pharmacy, biomedical engineering, quality, regulatory affairs, or another scientific or technical discipline
  • At least 8 years of experience in the medical device and/or IVD industry
  • Strong knowledge of EU MDR 2017/745 and/or EU IVDR 2017/746
  • Very good knowledge of IEC 62304 and medical device software lifecycle requirements
  • Experience with software medical devices and/or AI-enabled medical devices
  • Experience preparing and reviewing technical documentation for CE marking
  • Experience with international regulatory submissions, particularly in the United States, would be a strong advantage
  • Knowledge of electromedical devices and the IEC 60601 series would be highly valued
  • Experience with ISO 13485 audits and MDSAP would be an advantage
  • Professional proficiency in English
  • Fluency in French or Italian

Principal Consultant, Medical Devices Regulatory & Quality

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