Consultant Medical Devices Regulatory Affairs (AI & Machine Learning)
Qserve GroupGelderland, Netherlands
Posted August 9, 2025
Full Time
About the Company
Qserve Group is a global partner for regulatory, clinical, and quality compliance services for medical devices and in vitro diagnostics, as well as a CRO for medical device clinical trials.
Job Description
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.
Requirements
- 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.
