Neko Health - Regulatory Affairs Engineering Lead, AI/ML

Stockholm, Sweden3w ago

In Office Staff EMEA Medical Devices Digital Health Regulatory Affairs Manager Regulatory Affairs Sprint Planning Risk Management Reporting Mentoring

Requirements

• 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'd 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 judgment 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 advantage. • Familiarity with ISO 13485 QMS and integrating regulatory requirements into QMS processes is advantageous. • Previous experience in a high-growth, product-led health tech or digital health company is preferred. • Experience leading or mentoring a small regulatory or quality team is a plus.

Responsibilities

• 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 prioritized 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 minimize 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.

Benefits

• You will play a key role in shaping how Neko’s AI- and ML-powered software enters regulated markets, in an environment where both the technology and the regulatory landscape are still evolving. Rather than just maintaining compliance for an established framework, you will help build regulatory strategy and processes from the ground up and embed them directly into engineering practices. • End-to-end involvement with a focused, high-impact software portfolio, not just a small part of a large, bureaucratic function. • Close collaboration with engineering, clinical, and product teams in a company that designs and manufactures its own devices. • A small, experienced regulatory team where your judgment is valued and your contributions are visible. • Competitive salary and benefits package. • 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. • 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.