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Posted 6 hours ago
Regulatory Affairs Engineering Lead, AI/ML
Neko
Requirements
3+ years medical device regulatory experience, Expertise in EU MDR, IEC 62304, and FDA/UK MDR, Knowledge of EU AI Act and AI/ML SaMD
Skills
AI/ML
About the role
Responsibilities
- Develop and maintain regulatory strategy for AI/ML-based SaMD across EU MDR, FDA, and UK MDR
- Integrate IEC 62304 and EU AI Act obligations into software development workflows
- Prepare regulatory submissions and technical files, coordinating with engineering and clinical teams
Requirements
- Minimum 3 years of experience in regulatory affairs or quality management for medical devices
- Hands-on experience with SaMD regulation, EU MDR, IEC 62304, and FDA 21 CFR Part 820 or UK MDR
- Strong understanding of AI/ML regulatory requirements including the EU AI Act
About the Company
Neko is redefining what prevention means, moving from treating illness to sustaining health before it's at risk through data-driven, preventative care and proprietary technology.
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Neko · Stockholm
