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  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.

As the RA Engineering Lead for AI/ML Software, you will support the regulatory strategy for Neko’s AI- and ML-powered medical software, covering EU MDR, FDA, and UK MDR. You will collaborate closely with engineering, quality, and clinical teams, translating complex global requirements into clear, actionable steps for the organization. This is a hands‑on leadership role: you will actively contribute, build regulatory capability, and embed regulatory thinking within the software team’s operations.

• Assist in developing and maintaining Neko’s regulatory strategy for AI/ML-based SaMD across EU MDR, FDA, and UK MDR, providing engineering and product teams with a clear and prioritised compliance roadmap.
• Contribute to preparing regulatory submissions and technical files, coordinating input from engineering, clinical, and quality teams for review by notified bodies or agencies.
• Integrate IEC 62304 and EU AI Act obligations into software development workflows, working directly with engineering leads to ensure compliance is part of sprint cadences rather than an afterthought at release.
• Assess the regulatory impact of changes to software and AI/ML models, supporting change control activities.
• Design and deliver regulatory training for process owners and product teams to minimise rework due to late-stage regulatory findings.
• Support post-market surveillance for software modules, including regulatory change monitoring, incident reporting, and providing feedback into product development.
• Contribute to internal and external audits, and participate in interactions with notified bodies and regulatory agencies.
• Collaborate with engineering, clinical, product, and quality teams on regulatory and compliance matters for AI/ML software.

• You've worked hands‑on with SaMD regulation, EU MDR, IEC 62304, IEC 82304-1, and either FDA 21 CFR Part 820 or UK MDR, and you know the difference between what the regulation requires and what people assume it requires.
• AI/ML-specific rules like the EU AI Act and FDA’s AI/ML-Based SaMD Action Plan aren’t new territory for you. You can turn them into something an engineering team can actually act on, not just a document that sits in a folder.
• You would rather make a proportionate, risk-based call than run through a checklist, and you’re comfortable being the person who has to justify that call.
• You’re equally at home in a sprint planning session and drafting a submission, and you don’t need someone else to structure your workstream for you.
• You’re used to making judgement calls in a space where the technology and the regulations are both still moving.

• Bachelor’s or Master’s degree in engineering (preferred), another relevant scientific discipline, or equivalent professional experience.
• A minimum of 3 years of professional experience in regulatory affairs or quality management for medical devices.
• Working knowledge of EU MDR, IEC 62304, IEC 82304-1, and at least one of FDA 21 CFR Part 820 or UK MDR.
• Practical experience preparing regulatory submissions (technical files, 510(k) s, or similar) and managing notified body or agency interactions.
• Strong understanding of AI/ML regulatory requirements, including the EU AI Act and FDA AI/ML-Based SaMD Action Plan.
• Proven ability to translate complex regulatory obligations into practical guidance for engineering and product teams in a dynamic environment.
• Fluent in English (oral and written);
  Swedish proficiency is a plus.
• Experience with ISO 14971 risk management and IEC 81001-5-1 cybersecurity requirements in product development is an…