About Us
We're an ambitious startup building clinical AI software for the European healthcare market (and beyond). We use AI at its best - thoughtfully, responsibly and where it can make a meaningful difference - and give our team the best possible tools and equipment to create the greatest possible impact. As we grow, we need someone who can bridge the gap between fast-moving product development and the realities of building medical software under EU regulation.

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The Role
We're looking for a Product Manager who has hands-on experience bringing a product through MDR (Regulation (EU) 2017/745) conformity assessment and market authorisation - ideally within a medical device or Software as a Medical Device (SaMD) company. You'll act as the connective tissue between our Product, Engineering, Clinical, and Quality/Regulatory functions, making sure regulatory requirements are built into the product from day one rather than bolted on at the end.

This isn't a regulatory affairs role - you won't be writing technical documentation or leading conformity assessments yourself. But you need to have lived through that process closely enough to know what "regulatory-ready" actually means in practice, and to translate it into product decisions, roadmaps, and cross-functional priorities.

What You'll Do
Own the product roadmap for features with clinical or regulatory relevance, working closely with our regulatory/QA lead
Translate MDR, IEC 62304, ISO 14971, IEC 62366-1, and related requirements into concrete product and engineering requirements
Help define intended purpose, claims, and user workflows in a way that is defensible from a qualification/classification standpoint
Work with clinical, engineering, and design teams to ensure traceability, risk management, and usability requirements are reflected in the product lifecycle




Partner with Quality/Regulatory on technical documentation, change control, and post-market surveillance inputs that originate from product decisions
Prioritise and sequence features across non-regulated (MVP), Class I, and Class IIa+ scenarios, understanding the tradeoffs of each
Communicate regulatory constraints to the broader team in plain, practical language — no jargon walls

What We're Looking For
Prior experience as a Product Manager (or closely adjacent role) at a company that has taken a medical device or SaMD product through MDR authorisation
Solid working understanding of MDR, and ideally exposure to relevant standards (ISO 13485, ISO 14971, IEC 62304, IEC 82304-1)
Comfortable operating at the intersection of product, clinical, and regulatory worlds — you don't need to be a regulatory expert, but you need to speak the language
Background in Biomedical Engineering or a related field is a strong plus, but not required — what matters most is direct product experience in a regulated MedTech environment xdwybme
Strong product instincts: prioritisation, roadmap ownership, stakeholder alignment, and shipping
Excellent written and verbal English; comfortable working async in a remote-first, EU-distributed team

Nice to Have

Experience with AI/software-based medical devices specifically (rather than hardware devices)
Familiarity with the EU AI Act and how it interacts with MDR conformity assessment
Experience working with notified bodies or in preparation for a notified body audit

Logistics
Remote, must be based in the EU (time zone overlap for collaboration)
Full-time
Best-in-class equipment and tools to do your best work
Compensation: €50,000 – €65,000 gross per year, depending on experience and seniority

Interested? Send us your CV and a short note on the most regulated product decision you've had to make as a PM - what the constraint was, and how you navigated it.

📌 Product Manager with MDR Background (Roma)
🏢 Stealth Healthcare AI Startup
📍 Roma