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 authorization for the NIMBLE-II clinical investigation.
Background
Montse studied Industrial Technical Engineering at the Universitat Politècnica de Catalunya, but what really shaped her expertise has been the breadth of environments she moved through afterwards: Manufacturers, a Notified Body, multinationals, and start-ups. Each context has taught her something different about how the medical device industry actually works.
The clearest turning point came when she joined TÜV SÜD. Working across many companies and technologies as an auditor gave her a 360-degree view of the sector, the kind of foundation that’s difficult to build and it still shapes how she approaches challenges today.
What Regulatory Affairs Actually Means Here
Most people picture Regulatory Affairs as mountains of paperwork and submission checklists. Montse would disagree.
«Many people think it’s mainly about regulations and documentation,» she says. But for her, the role is really about being at the crossroads of science, technology, quality, and business. In practice, that means being involved in many of the key decisions that shape a medical device, from development and clinical evidence generation to market access and post-market activities.
The key is understanding requirements before they become problems, anticipating challenges, and working closely with different teams to ensure innovative technology can be developed, clinically evaluated, approved, and ultimately reach patients safely and effectively.
A Member of Our Team
What Montse appreciates most about NIMBLE is the trust and flexibility she’s given and being close to leadership when decisions matter. The team is young, international, and open. People come from different backgrounds and that shows in how ideas get discussed and challenged. She values the international dimension of the team and the chance to work in English every day, which keeps her learning and adapting.
From here, her focus is on helping NIMBLE make the jump from innovation to market. That means building out the regulatory and quality framework, supporting the clinical evidence work, and getting everything in place for approvals in Europe and the US.
Outside of Work
The auditor mindset doesn’t really clock out when she leaves the office! Montse tends to notice how things work, and where they could be improved. That same curiosity leads her to keep up with new technologies in her own time.
When she’s not at work, she’s with family and friends, at a rock concert, or enjoying motorcycle rides whenever she gets the chance.
If she could choose one word for the whole journey: Passionate
