Product Manager with MDR Background
Pubblicato il 03-08-2026 - Stealth Healthcare AI Startup in Terni
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.
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
- 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.