Senior Regulatory Affairs Engineer (AI/ML)
Neko Health
Software Engineering, Data Science, Compliance / Regulatory
Europe
Posted on Oct 14, 2025
Join Neko Health as Senior Regulatory Affairs Engineer
Are you ready to shape the future of medical technology? Neko Health is seeking a Senior Regulatory Affairs Engineerwho’s passionate about tackling complex regulatory strategies, enjoys working with cutting-edge medical devices, and thrives in a fast-paced, collaborativeand distributed environment.
We are looking for you that have extensive experience from software development, artificial intelligence, and machine learning in the medical device space.
What You’ll Do
- Drive Regulatory Excellence: Ensure our cutting-edge software meets global standards and regulations as well as align with regulatory strategies from research and development to market launch and post-market.
- Implement Regulatory Requirements for AI and ML: Coordinate activities and efforts across AI and ML algorithms and device software implementation and ensure regulatory requirements are implemented in our processes.
- Support Software Development: Advise on regulatory strategy throughout the software lifecycle, influencing architecture and design, risk management, supplier selection, and labeling.
- Prepare Software Documentation: Participate in activities to prepare necessary software documentation for our software modules, components, algorithms, and devices as needed.
- Empower Process Owners and Teams: Guide process owners and product teams to integrate regulatory requirements into our Quality Management System and deliver impactful training on compliance and regulatory topics.
- Stay Ahead: Monitor regulatory trends and provide intelligence to keep Neko Health at the forefront of compliance.
What You Bring
- Education: BSc or MSc in law, medicine, pharmacy, engineering, or a related field.
- Experience: 4–5+ years in software development with artificial intelligence and machine learning algorithms. Experience from regulatory affairs or quality management for software as a medical device is a plus.
- Expertise: Deep knowledge of EU AI Act, FDA AI Guidance, IEC 62304, IEC 82304-1, IEC 81001-5-1. Knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, ISO 14971, and more is a plus.
- Skills: Analytical, detail-oriented, and able to interpret complex regulations to provide risk-based recommendations.
- Communication: Excellent interpersonal and writing skills; able to engage and inspire both internal teams and external stakeholders.
- Mindset: Self-motivated, independent, and ready to take ownership in a dynamic, quality-focused environment.
- Languages: Fluent English required; Swedish proficiency is a plus.