Candice Bautista
About Candice

Building the regulatory strategies behind healthcare innovation.

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

About Me

I work at the intersection of healthcare, technology, and regulation, helping innovative companies bring AI-enabled medical technologies to patients safely and responsibly.

Over the past decade, I've led regulatory strategy across diagnostics, software as a medical device, and oncology—from FDA De Novo authorization for first-of-kind technologies to global regulatory planning and quality systems. Today, I lead regulatory affairs for an AI diagnostics company, where I partner with engineers, clinicians, scientists, and executives to navigate complex regulatory challenges and build organizations that can scale.

I believe regulation is most effective when it's collaborative, pragmatic, and grounded in the science. My goal isn't simply to achieve approval — it's to help build products that earn the trust of regulators, clinicians, and, most importantly, patients.

Beyond Work

Adventure

Whether I'm climbing, backpacking, or exploring somewhere new, I enjoy experiences that challenge me and broaden my perspective.

Parenting

Raising a curious little human—and learning alongside him.

Lifelong Learning

Always reading something that challenges how I think, from psychology and leadership to healthcare and technology.

Building

I enjoy creating things that last—whether that's a regulatory function, a personal project, or a new skill.