Candice Bautista
About

I help good ideas earn the right to reach patients.

Candice Bautista

My Journey

  1. 01PharmD
  2. 02Regulatory Affairs
  3. 03AI/ML Medical Devices
  4. 04De Novo Experience
  5. 05Head of Regulatory Affairs
  6. 06Advisor & Consultant

Professional Bio

I lead regulatory affairs for an AI diagnostics company, where I work at the intersection of machine learning and FDA policy — two fields that move fast, rarely in the same direction, and need someone fluent in both.

My background spans diagnostics, software as a medical device, and oncology, with hands-on experience securing De Novo authorization for novel technology. I’ve since moved from individual contributor to building and leading regulatory functions inside healthcare startups, where the work is equal parts strategy, translation, and judgment calls made with incomplete information.

What I care about most is simple: that the technology genuinely helps patients, and that we can prove it. Everything else — the pathway, the documentation, the FDA meetings — is in service of that.

Beyond Work

Rock Climbing

Most weekends, somewhere on Colorado's Front Range.

Colorado Lifestyle

Trail running, cycling, and a deep love of altitude.

Travel

New cities, new clinics, new ways of doing things well.

Parenting

Raising a curious kid and trying to keep up with him.

Lifelong Learning

Currently working through David Brooks' How to Know a Person.