About

Dr. Irina Idler

Regulatory Solution Architect with a doctorate in molecular biology and a master's in Clinical Trial Management — with years of involvement in EU MDR and IVDR clinical evaluation. Before that, years in cancer research — and later, programme director for Regulatory Affairs Management at the Johner Institute, where I taught scientific writing. The scientific method has always been the foundation of how I work.

What matters to me is this: people should have more time for the work they love, and get their creativity back. You cannot think clearly when you are buried under documentation, and you cannot make real choices either. Enablement means giving people their choices back — AI takes on what AI can, so the human carries what only the human can.

In practice, this means I work at the intersection of regulatory expertise and AI: I build AI solutions for clinical evaluation under EU MDR and IVDR, I write the regulatory documentation myself when teams need that capacity, and I run enablement programmes for Clinical Affairs teams who want to do this work themselves — with the methodology, the tooling, and the confidence to defend it.