Consultant Medical Devices Regulatory Affairs

3 dagen geleden

Arnhem, Gelderland, Nederland Qserve Group B.V. Voltijd

Qserve is seeking a Regulatory Consultant with expertise in Artificial Intelligence (AI) and Machine Learning (ML) for medical devices and IVDs. In this role, you will support clients in navigating complex regulatory landscapes for innovative technologies, including Software as a Medical Device (SaMD) and AI-enabled IVDs. You will work closely with global experts to ensure regulatory compliance and market access for cutting-edge healthcare solutions.

What you'll do

  • Advise clients on regulatory strategies for AI/ML-based medical devices, IVDs, and SaMD.
  • Prepare and review technical documentation for medical devices and IVDs.
  • Support clients with regulatory submissions and responses to questions from regulatory authorities.
  • Guide clients through design and development processes, risk analysis, and compliance requirements.
  • Stay up to date with evolving regulations, including the EU MDR, IVDR, FDA guidelines, and the AI Act.
  • Manage multiple projects and deliver results within agreed timelines.
  • Communicate complex regulatory topics effectively to both technical and non-technical stakeholders.

What you'll bring

  • Technical or scientific degree (BSc, MSc, or PhD) in engineering, biomedical technology, computer science, or a related field.
  • Minimum of 4 years' experience in the medical device sector (EU MDD and EU MDR), gained in industry, consultancy, or Notified Body roles.
  • Hands-on experience with AI/ML-based devices, either in regulatory affairs or as a design engineer.
  • Experience preparing technical documentation and regulatory submissions for SaMD and AI-enabled IVDs.
  • Familiarity with ISO 13485 and medical device Quality Management Systems.
  • Strong knowledge of regulatory frameworks for AI/ML (e.g., EU AI Act, US Good Machine Learning Practices) is a plus.
  • Pragmatic and service-oriented, with the ability to manage multiple projects simultaneously.
  • Excellent communication skills in English; Dutch is an advantage.

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