Jennifer Dixon

I am an AI-Native Quality and Regulatory Affairs leader with 7+ years of experience spanning AI/ML SaMD, FDA submissions, Agile Software Development, and QMS implementation. I've led 510(k) clearances, Pre-Submission engagements, and audit-ready QMS builds from the ground up — often under tight timelines with bespoke computational controls (eQMS). I'm a licensed engineer (P.Eng), RAC-Devices holder, and ISO 13485 Lead Auditor, and I speak regularly at RAPS and other global conferences on AI governance and regulatory strategy for adaptive medical devices.

I'm drawn to this work because helping safety-critical software reach patients actually matters. I love working with new teams and new technologies — the best parts of this work has always been the partnerships, getting into their hardest problems, and figuring it out together.