---
bio: I spent 22 years at FDA's Center for Devices and Radiological Health (CDRH),
  where I directed more than 150 Advisory Committee meetings and worked extensively
  with 510(k), PMA, De Novo, and related regulatory pathways. I'm looking forward
  to bringing that experience to help our clients design, document, and clear safe,
  effective software and AI medical devices.
hire_date: '2026-08-24'
hobbies: Traveling with my wife and 2 kiddos, any type of outdoor sports or hiking
  and exploring new restaurants with my wife!
linkedin: null
name: James Swink
photo: /img/people/James_Swink-3c3bd5b7a75480fcb532d043baa2215e.jpeg
skills: ''
testimonials: []
title: Principal Regulatory Consultant
---