At a Glance
- Tasks: Lead regulatory strategy for AI/ML software in healthcare across multiple markets.
- Company: Neko Health, a forward-thinking company in the health tech sector.
- Benefits: Competitive salary, flexible working hours, and opportunities for professional growth.
- Other info: Join a dynamic team dedicated to making a difference in health tech.
- Why this job: Shape the future of healthcare technology while ensuring compliance and innovation.
- Qualifications: Experience in regulatory engineering and strong leadership skills.
The predicted salary is between 60000 - 80000 £ per year.
Neko Health in Manchester seeks an RA Engineering Lead for AI/ML SaMD to shape regulatory strategy across EU MDR, FDA and UK MDR. You will work hands-on with engineering, quality and clinical teams to translate complex requirements into actionable plans that fit sprint cadences.
This leadership role blends technical influence with risk-based decision making, builds regulatory capability inside the software team, and ensures compliant, timely submissions as Neko expands in regulated markets.
We think you need these skills to ace AI/ML SaMD Regulatory Engineering Lead
Regulatory Strategy Development
EU MDR Knowledge
FDA Regulations Knowledge
UK MDR Knowledge
Technical Influence
Risk-Based Decision Making
Collaboration with Engineering Teams
