Jim Williams
About Jim Williams
I have 18 years of experience providing full lifecycle regulatory and technical support to life science and government organizations developing, upgrading, or maintaining software systems, medical devices, and Software as a Medical Device (SaMD) apps & wearables, including those utilizing machine learning.Among my recent projects at Guidehouse (formerly Navigant) are • leading an FDA 510(k) submission effort for a wearable device that utilizes machine learning; • leading SaMD development workstreams for a remote clinical trial system and a CGM wearable utilizing machine learning; • leading development workstreams for pharma company apps under FDA enforcement discretion; • leading software retrospective documentation workstream for a clinical decision support EU tech file; • partnering on a design controls (21 CFR 820.30) gap assessment and remediation plan for a tech company seeking to enter the medical device market; and • providing multiple rounds of feedback against U.S. regulations, guidance, and recognized consensus standards for extensive software documentation for an EU company seeking to commercialize its medical devices in the U.S.I also support my Guidehouse colleagues serving as expert witnesses in complex litigation with project management, large-scale document review, Rule 26-compliant report preparation, and conducting mock depositions. Additionally, I compose FDA regulatory and healthcare compliance (e.g., HHS-OIG) policies, regulatory strategies and opinions, audit reports, M&A due diligence reports, and responses to FDA-483s and Warning Letters.I previously worked for the State of Indiana, where I collaborated for eight years with a Big Four consultancy, playing a critical role on numerous high-profile, large-scale software projects, including serving as co-lead tester on a complex, multi-year $1.6B project to modernize a state welfare computer system.I am a member of the Regulatory Affairs Professionals Society (RAPS).