At a Glance
- Tasks: Lead regulatory compliance for AI/ML software, collaborating with engineering and clinical teams.
- 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 focused on innovation and impactful health solutions.
- Why this job: Shape the future of health tech while ensuring compliance and making a real difference.
- Qualifications: Experience in regulatory affairs and a strong understanding of AI/ML technologies.
The predicted salary is between 60000 - 80000 £ per year.
Neko Health is seeking an RA Engineering Lead for AI/ML Sa MD regulatory to drive compliance across EU MDR, FDA and UK MDR.
You will partner with engineering, quality and clinical teams to translate complex requirements into actionable plans and embed regulatory thinking into sprint cadences.
This hands‑on leadership role balances strategic development of regulatory strategy with hands‑on submissions, audits, and training.
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We think you need these skills to ace AI/ML SaMD Regulatory Lead Engineer
Regulatory Compliance
EU MDR Knowledge
FDA Regulations
UK MDR Knowledge
AI/ML Understanding
Cross-Functional Collaboration
Strategic Development