Product Manager With Mdr Background

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79z0up

?About UsWe'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 RoleWe'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 DoOwn the product roadmap for features with clinical or regulatory relevance, working closely with our regulatory/QA leadTranslate MDR, IEC 62304, ISO 14971, IEC 62366-1, and related requirements into concrete product and engineering requirementsHelp define intended purpose, claims, and user workflows in a way that is defensible from a qualification/classification standpointWork with clinical, engineering, and design teams to ensure traceability, risk management,



and usability requirements are reflected in the product lifecyclePartner with Quality/Regulatory on technical documentation, change control, and post-market surveillance inputs that originate from product decisionsPrioritise and sequence features across non-regulated (MVP), Class I, and Class IIa+ scenarios, understanding the tradeoffs of eachCommunicate regulatory constraints to the broader team in plain, practical language — no jargon walls?What We're Looking ForPrior experience as a Product Manager (or closely adjacent role) at a company that has taken a medical device or SaMD product through MDR authorisationSolid 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 languageBackground 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 environmentStrong product instincts: prioritisation, roadmap ownership, stakeholder alignment, and shippingExcellent written and verbal English; comfortable working async in a remote-first, EU-distributed team⭐Nice to HaveExperience with AI/software-based medical devices specifically (rather than hardware devices)Familiarity with the EU AI Act and how it interacts with MDR conformity assessmentExperience working with notified bodies or in preparation for a notified body audit?LogisticsRemote, must be based in the EU (time zone overlap for collaboration)Full-timeBest-in-class equipment and tools to do your best workCompensation: €50,000 – €65,000 gross per year, depending on experience and seniorityInterested? 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.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79z0up