Ainoa Forteza is Alira Health’s Vice President of Regulatory Affairs Medtech, where she leads her team on FDA and EU submissions across multiple therapeutic areas and device risk classes.

With over 10 years of experience in regulatory affairs consulting, Ainoa’s strategic work includes regulatory strategies, gap analysis, and product positioning refinement. On the operational side, she has secured CE marks for medical devices and IVDs in the EU and has engaged with the FDA in the US through various interactions including Pre-Submission, IDE, BDD, 513(g),510(k), De Novo, and PMA submissions.

Prior to joining Alira Health, Ainoa worked at Drug Development and Regulation S.L. (DDR), now part of Veristat, where she managed a team focused on product strategy and manufacturer compliance.

Ainoa is a human biologist and holds a Master’s degree in Pharmaceutical and Biotechnology Industry from Pompeu Fabra University, as well as a postgraduate degree as an expert in medical devices from the University of Barcelona.