pstrong About Us /strongp 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. /pp Scopra se questa occasione è adatta a lei leggendo tutte le informazioni riportate di seguito. brpstrong The Role /strong /pp We're looking for a Product Manager who has hands-on experience bringing a product through b MDR (Regulation (EU) 2017/745) /b b conformity assessment and market authorisation /b - 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. /p p 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. /p p strong What You'll Do /strong /pulli Own the product roadmap for features with clinical or regulatory relevance, working closely with our regulatory/QA lead /lili Translate MDR, IEC 62304, ISO 14971, IEC 62366-1, and related requirements into concrete product and engineering requirements /lili Help define intended purpose, claims, and user workflows in a way that is defensible from a qualification/classification standpoint /lili Work with clinical, engineering, and design teams to ensure traceability, risk management,



and usability requirements are reflected in the product lifecycle /lili Partner with Quality/Regulatory on technical documentation, change control, and post-market surveillance inputs that originate from product decisions /lili Prioritise and sequence features across non-regulated (MVP), Class I, and Class IIa+ scenarios, understanding the tradeoffs of each /lili Communicate regulatory constraints to the broader team in plain, practical language — no jargon walls /li /ul pstrong What We're Looking For /strong /pulli 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 /lili Solid working understanding of MDR, and ideally exposure to relevant standards (ISO 13485, ISO 14971, IEC 62304, IEC 82304-1) /lili 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 /lili 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 xrdbqlu /lili Strong product instincts: prioritisation, roadmap ownership, stakeholder alignment, and shipping /lili Excellent written and verbal English; comfortable working async in a remote-first, EU-distributed team /li /ul p Nice to Have /p ulli Experience with AI/software-based medical devices specifically (rather than hardware devices) /lili Familiarity with the EU AI Act and how it interacts with MDR conformity assessment /lili Experience working with notified bodies or in preparation for a notified body audit /li /ul pstrong Logistics /strong /pulli Remote, must be based in the EU (time zone overlap for collaboration) /lili Full-time /lili Best-in-class equipment and tools to do your best work /lili Compensation: €50,000 – €65,000 gross per year, depending on experience and seniority /li /ul p 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. /p /p /p

📌 Product Manager with MDR Background (Città Metropolitana di Torino)
🏢 Stealth Healthcare AI Startup
📍 Città Metropolitana di Torino