About the role
Mission Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear. In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives. 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. About titles at Neko We use a simplified internal title framework that prioritises clarity over hierarchy, so internal titles may differ from market‑facing role titles. Scope, impact and level of
