Introducing Montse Gutiérrez: Regulatory Affairs and Quality Assurance Director
At NIMBLE, every team member brings a distinct perspective to the table. Today, we’re spotlighting Montse Gutiérrez, our RAQA Director, who joined us in April 2025. Her role sits at the crossroads of innovation and compliance, to ensure NIMBLE’s vision can actually reach patients, legally, safely, and credibly. Since joining, Montse has established the quality and regulatory framework that underpins product development, clinical investigations, and the company’s path toward global market access. That includes early involvement in the FDA Breakthrough Device Designation program and the regulatory work required to obtain …
