Manager Product and Regulatory Strategy - MedTech & AI (m/w/d)

Most medical AI learns patterns without knowing why. At Simultare, we're taking a different path: we're building the most transparent and reliable anatomical AI, one that combines deep medical expertise with machine intelligence and can explain every single result it delivers.
Our goal is nothing less than to redefine how surgeons plan and prepare, with technology that clinicians can trust because they can follow its reasoning.
We're a young MedTech startup at the intersection of surgery, knowledge and artificial intelligence, and we're looking for someone to help turn this vision into a product.
🎯Your role
You bring together two worlds that many companies keep apart. You make sure our products reach the market with regulatory excellence, and you actively shape the roadmap of our products.
📋Your responsibilities
Own the regulatory strategy for our product portfolio, including classification, conformity assessment routes, and approval planning for our target markets.
Guide our technical team in preparing technical documentation and coordinate with Notified Bodies and authorities.
Monitor regulatory developments such as the MDR, the EU AI Act, and changes to standards, and assess their impact on our products and roadmap.
Support the ongoing development of our quality management system and accompany audits.
Assist in monitoring product development from idea to launch, track milestones, identify risks early, and work closely with engineering, sales, and customers.
Embed regulatory requirements into the development process from day one (regulatory by design) to avoid costly rework.
Evaluate market and competitive developments and derive product decisions from them.
Report regularly on roadmap status, regulatory progress, and product KPIs.
🛠 What you bring
A degree in medical engineering, life sciences, engineering, (business) informatics, or a comparable qualification
Experience in Regulatory Affairs in a regulated environment, ideally including approvals you led yourself
In-depth knowledge of the MDR (EU 2017/745), ISO 13485, and ISO 14971. Knowledge of IEC 62304 is a plus for software products.
Experience in product management or product development, such as roadmap ownership, requirements management, or working with agile development teams
A structured, independent way of working and the ability to switch between detail (documentation) and big picture (strategy)
Confidence in dealing with authorities, Notified Bodies, and senior management
Fluent German and English
✨Nice to have
Experience in a startup or scale-up environment
Familiarity with tools such as Jira, Confluence, or eQMS systems
🤝What we offer
A key role with real room to shape things and a direct line to management
100% remote, with occasional on-site team meetings (mainly around Nagold / southern Germany)
Flexible Working Hours

Work arrangement
Yes