Regulatory AI/ML Software Lead

Neko Health; Stockholms kommun; On-site; SEK 1,000,000 - 1,400,000; Full time

Benefits offered by this job

Competitive salary

Hybrid work

Small regulatory team

Impactful work improving health

Job summary

Neko Health is seeking an experienced RA Engineering Lead for AI/ML Software to shape regulatory strategy for AI/ML powered medical software across EU MDR, FDA and UK MDR. You will collaborate with engineering, quality and clinical teams to translate complex requirements into actionable plans for the organization.

This hands‑on leadership role blends regulatory thinking with software delivery, building capability and embedding compliance into sprint cadences to help bring safe, effective digital

Qualifications

• Bachelor’s or Master’s degree in engineering or related field (or equivalent).
• Minimum of 3 years of professional experience in regulatory affairs or quality management for medical devices.
• Experience with EU MDR, IEC 62304, IEC 82304-1, and at least one of FDA 21 CFR Part 820 or UK MDR.
• Fluent in English; Swedish proficiency is a plus.
• Experience leading or mentoring a small regulatory or quality team is a plus.

Responsibilities

• Develop and maintain regulatory strategy for AI/ML-based SaMD across EU MDR, FDA, and UK MDR.
• Prepare regulatory submissions and coordinate input from engineering, clinical, and quality teams.
• Integrate IEC 62304 and EU AI Act obligations into software development workflows.
• Assess regulatory impact of changes to software and AI/ML models.
• Design regulatory training and support post-market surveillance and audits.

Skills

Regulatory strategy for SaMD

EU MDR & IEC 62304 knowledge

AI/ML regulatory requirements

Regulatory submissions

Education

Bachelor’s or Master’s degree in engineering or related field

Job description

Neko Health is seeking an experienced RA Engineering Lead for AI/ML Software to shape regulatory strategy for AI/ML powered medical software across EU MDR, FDA and UK MDR. You will collaborate with engineering, quality and clinical teams to translate complex requirements into actionable plans for the organization.

This hands‑on leadership role blends regulatory thinking with software delivery, building capability and embedding compliance into sprint cadences to help bring safe, effective digital