Candice Bautista, PharmD
Head of Regulatory Affairs · Boulder, Colorado
I help healthcare companies navigate complex regulatory challenges — from first-of-kind AI-enabled medical devices to global market expansion. Over the past decade I’ve led FDA De Novo submissions, Breakthrough Device Designations, global regulatory strategy, and quality systems for startups and established MedTech organizations.
10+
Years in Regulatory Affairs
20+
Regulatory Meetings Led
4
FDA Authorizations
1
Breakthrough Device Designation
Professional Experience
Head of Regulatory Affairs
2026 – PresentValar Labs
- Leading regulatory strategy for AI-powered software as a medical device, building the regulatory function, and partnering with executive leadership to bring innovative technologies to patients.
Regulatory Strategy Advisor
2026 – PresentRellia Health
- Providing strategic regulatory guidance for emerging healthcare technologies.
Regulatory Affairs Manager
2024 – 2026Artera
- Led regulatory strategy for FDA De Novo authorization and 510(k) clearance for AI/ML oncology products.
- Secured Breakthrough Device Designation and guided long-term FDA strategy.
Regulatory Affairs Program Manager
2021 – 2024Cleerly
- Helped bring AI-enabled cardiovascular imaging technologies to the US market.
Senior Regulatory Affairs Specialist
2017 – 2021Medtronic
- Led global regulatory strategy across robotic-assisted surgery and electrosurgical devices, supporting FDA clearance, EU MDR implementation, and international market expansion.
Selected Achievements
- Led successful FDA De Novo authorization for an AI-enabled diagnostic.
- Secured multiple Breakthrough Device Designations.
- Directed regulatory strategies across the US, EU, UK, Canada, and Australia.
- Built and scaled regulatory and quality functions within venture-backed startups.
- Led FDA interactions from pre-submission through marketing authorization.
Core Expertise
Education
Doctor of Pharmacy (PharmD)
MCPHS University
B.S. Neuroscience
Brandeis University
My Approach
I believe effective regulatory strategy is about more than compliance. It’s about helping organizations make thoughtful decisions, reduce uncertainty, and build products that earn the trust of regulators, clinicians, and patients.