Entrepreneurial CTO and co-founder for an AI spin-off company

We are looking for a visionary technical co-founder to lead the development of an innovative, customer-facing regulatory software-AI platform. The solution will help medical device and AI/ML developers comply with the EU Medical Device Regulation (MDR) and upcoming AI Act, with a core focus on post-market surveillance, performance monitoring, and transparency across the AI lifecycle.

To build a next-generation compliance intelligence platform that bridges the regulatory gap for AI-enabled medical technologies — turning regulatory friction into digital opportunity.

As co-founder and technical lead, you will drive:

• Product architecture and development — from concept to scalable MVP and beyond.

• Technical decision-making, team building, and roadmap definition.

• Close collaboration with the CEO/co-founder (a regulatory and strategy expert) and with early customers, Notified Bodies, and MedTech partners.

Ideal Profile: Software Architect with a Builder’s Mindset

Technical/Engineering Expertise

·         Proven hands-on development experience, ideally in SaaS, AI/ML, or regulatory tech.

·         Strong backend architecture capabilities and familiarity with frontend technologies.

·         Experience integrating AI/ML pipelines, with an understanding of MLOps, model versioning, data management and real-world health data workflows.

Entrepreneurial Traits

·         You can build and lead a Software development team and make them work together towards a successful product.

·         You’re a zero-to-one builder who thrives in uncertainty and low-resource environments.

·         Decisive and collaborative — ready to help shape product, culture, and go-to-market strategy.

·         Comfortable engaging with users, advisors, and regulators to iterate toward product-market fit.

Bonus Points For:

·         Interest in the evolving regulation of medical AI (MDR, AI Act).

·         Some exposure to regulated environments, or readiness to learn clinical evaluation, risk management, and post-market surveillance processes.

·         Experience with health data standards (e.g., FHIR, HL7) and cybersecurity (e.g., ISO 27001).

·         Previous roles in startups, particularly in founding or early technical leadership.

·         Experience with biomedical engineering,  compliance automation, or medical AI.

·         Familiarity with GDPR, AI Act, cybersecurity infrastructure, GxP, 21 CFR Part 11, MDR, IVDR, or ISO 13485/14971.

Location

·         Remote-friendly, with preference for candidates based in Belgium.