Regulatory Affairs Engineering Lead (AI/ML)

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. Role Purpose As the Regulatory Affairs Engineering Lead at Neko Health, you will own the regulatory strategy for our AI- and ML-powered medical software, setting the frameworks and cross-functional processes that let us ship compliant, safe devices at pace. You will be the connective tissue between engineering, quality, and clinical teams, translating complex global requirements into clear actions that the organisation can execute. This is a hands-on lead role: you will do the work, build the capability, and shape how regulatory thinking is embedded across Neko. What You'll Deliver in the First 6–12 Months · Publish Neko's regulatory strategy for AI/ML-based SaMD across EU MDR, FDA, and UK MDR, giving engineering and product teams a clear, prioritised compliance roadmap they can act on immediately. · Lead end-to-end preparation of at least one regulatory submission or technical file, coordinating engineering, clinical, and quality inputs and seeing it through to notified body or agency review. · Embed IEC 62304 and EU AI Act obligations into existing software development workflows, working directly with engineering leads so compliance is built into sprint cadences rather than bolted on at release. · Design and deliver a regulatory training programme for process owners and product teams, with measurable improvement in compliance awareness and a reduction in rework caused by late-stage regulatory findings. · Stand up a post-market surveillance process for our software modules, covering regulatory change monitoring, incident reporting, and feedback loops into the product development cycle. Minimum Qualifications · 6+ years in regulatory affairs or software quality for medical devices, including at least 2 years in a lead or senior individual contributor role. · Deep expertise in SaMD regulations: EU MDR, IEC 62304, IEC 82304-1, and at least one of FDA 21 CFR Part 820 or UK MDR. · Hands-on experience preparing regulatory submissions (technical files, 510(k)s, or equivalent) and managing notified body or regulatory agency interactions. · Strong working knowledge of AI/ML regulatory requirements, including the EU AI Act and FDA AI/ML-Based SaMD Action Plan. · Track record of translating complex regulatory obligations into actionable guidance for engineering and product teams in a fast-moving environment. · Fluent English required; Swedish proficiency is a plus. Preferred · Experience applying ISO 14971 risk management and IEC 81001-5-1 cybersecurity requirements in a product development context. · Familiarity with ISO 13485 quality management systems and embedding regulatory requirements into QMS processes. · Prior experience in a high-growth, product-led health tech or digital health company. · Experience leading or mentoring a small regulatory or quality team. 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 the role are fully aligned and will be clearly discussed throughout the process. Hiring Process Candidates progress from application and structured screening through thoughtfully designed interviews culminating in a formal offer and final pre-employment checks before joining the team. Equal Opportunity & Inclusion Statement Neko Health is committed to inclusive hiring and member-first care. We welcome candidates from all backgrounds and encourage you to request reasonable adjustments to support your application.