Regulatory Affairs Engineering Lead, AI/ML

Neko Health; Stockholms kommun; On-site; SEK 1,000,000 - 1,400,000; Full time

Benefits offered by this job

Competitive salary

Hybrid work

Small regulatory team

Impactful work improving health

Job summary

Neko Health is seeking an experienced RA Engineering Lead for AI/ML Software to shape regulatory strategy for AI/ML powered medical software across EU MDR, FDA and UK MDR. You will collaborate with engineering, quality and clinical teams to translate complex requirements into actionable plans for the organization.

This hands‑on leadership role blends regulatory thinking with software delivery, building capability and embedding compliance into sprint cadences to help bring safe, effective digital

Qualifications

• Bachelor’s or Master’s degree in engineering or related field (or equivalent).
• Minimum of 3 years of professional experience in regulatory affairs or quality management for medical devices.
• Experience with EU MDR, IEC 62304, IEC 82304-1, and at least one of FDA 21 CFR Part 820 or UK MDR.
• Fluent in English; Swedish proficiency is a plus.
• Experience leading or mentoring a small regulatory or quality team is a plus.

Responsibilities

• Develop and maintain regulatory strategy for AI/ML-based SaMD across EU MDR, FDA, and UK MDR.
• Prepare regulatory submissions and coordinate input from engineering, clinical, and quality teams.
• Integrate IEC 62304 and EU AI Act obligations into software development workflows.
• Assess regulatory impact of changes to software and AI/ML models.
• Design regulatory training and support post-market surveillance and audits.

Skills

Regulatory strategy for SaMD

EU MDR & IEC 62304 knowledge

AI/ML regulatory requirements

Regulatory submissions

Education

Bachelor’s or Master’s degree in engineering or related field

Job description

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 Overview

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.

What You’ll Do

• 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.

Who You Are

• 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 judgement calls in a space where the technology and the regulations are both still moving.

Background And Experience

• 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.

Why This Role Is Unique

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.

What We Offer

• 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.

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.