VP, Regulatory Affairs & Compliance
Jordan John is the Vice President of Regulatory Affairs & Compliance at Blue Goat Cyber, where he owns the regulatory and compliance lane across FDA premarket and postmarket medical device submissions. He aligns cybersecurity evidence with FDA Section 524B, the Feb 3, 2026 premarket cybersecurity guidance, and eSTAR structure so every package holds together end-to-end for CDRH review.
Jordan partners with engineering, quality, and regulatory teams to translate cybersecurity expectations into concrete artifacts - threat models, SBOMs, security risk assessments, architecture views, and pen test evidence - that map cleanly to AAMI SW96, AAMI TIR57/97, IEC 81001-5-1, and ISO 14971. His focus is a submission-ready package the whole product team can defend on first review.
A frequent speaker on FDA cybersecurity strategy, Jordan has presented sessions such as "Compliance Without Chaos: Mastering FDA Cybersecurity" and co-hosted the Med Device Cyber Podcast webinar on the five key FDA cybersecurity standards.
30-minute strategy session. No cost, no commitment - just answers from people who've shipped 275+ devices supported.
