About
Built by a regulatory professional, not a tech startup
Zach Galloway
Founder, RegulatoryIQ
Quality and regulatory affairs leader with 14+ years guiding medical device, pharmaceutical, Software as a Medical Device (SaMD), and clinical trial programs through global regulatory requirements. Hands-on experience leading regulatory and quality operations across FDA, EU MDR, MHRA, TGA, Health Canada, PMDA, ISO 13485, and ICH GCP frameworks.
- No critical findings across 60+ completed regulatory and Sponsor/CRO audits
- Led quality operations through a $13M digital therapeutics merger, harmonizing QMS processes and maintaining multi-framework compliance
- Built SaMD validation frameworks supporting FDA pre-submissions, 510(k), and De Novo applications
- Compressed CAPA resolution timelines by 59% and reduced audit findings by 60% through process optimization
- Consulting engagements spanning medical device compliance, usability engineering (IEC 62366-1), data integrity risk assessments, QMSR/ISO 13485 mock audits, and QMS buildout for healthcare technology platforms
- Combines deep regulatory expertise with AI and machine learning capabilities, including development of this platform
"Every template and assessment is built from hands-on audit experience, not generated by AI and left unreviewed. When you buy from RegulatoryIQ, you're getting the same frameworks I use in real consulting engagements."
RAC Regulatory Affairs Certification – RAPS
CMQ/OE Manager of Quality/OE – ASQ
CPHQ Healthcare Quality – NAHQ
ACRP-CP Clinical Research – ACRP
ACRP-MDP Medical Device Professional – ACRP
Lead Auditor ISO 9001, 13485, 27001
LSSBB Lean Six Sigma Black Belt
RIMS-CRMP Certified Risk Management
AiE AI Engineer – ARTiBA
GCP ML Google Cloud Prof. ML Engineer
AWS ML AWS Machine Learning, Specialty
AIGP AI Governance Professional – IAPP