?
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 produc

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