SENIOR REGULATORY AFFAIRS SPECIALIST
Joined: May 15, 2026
Over 5+ years leading FDA submissions I have taken a SaMD through 510(k) clearance (K222359), Health Canada licensing, and CE marking, and led 5+ MDSAP and ISO 13485 audits. I hold RAC-Devices, P.Eng, and ISO 13485 Lead Auditor credentials, have led 5+ MDSAP, ISO 13485, and MDR audits, and speak at RAPS Convergence, RAPS Euro Convergence, and INCOSE on AI/ML SaMD regulatory strategy, PCCPs, and GMLP. At Innolitics I manage FDA Pre-Submissions and 510(k) programs for AI/ML SaMD clients, including a completed Pre-Sub for Apellai. I do this work because safety-critical software reaching patients matters, and the best part is digging into a team's hardest problems together.
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.
🧵Sewing, 🤸♀️Pilates, ✈️Travel, 🕹️Video Games, 🦫🇨🇦 🏕️ 🚣 Camping