Jesse H.

Get your application ISO 27001 certified, HIPAA compliant, GDPR ready, or FDA defensible. I write the policies, procedures, and compliance frameworks that regulated companies need to pass audits and launch. GDPR. HIPAA. ISO 9001. ISO 27001. FDA 21 CFR Part 11. A lot of the applications I work on use AI, so when it is in the stack I handle it correctly rather than ignoring it. 27 years in regulated industries. 300+ templates. My trademarked AAIG methodology. I am not a consultant who says "no." I find the "yes, if we do it this way" path that lets you move fast and stay compliant. WHAT I BUILD Policies, Procedures, and Quality Management. SOPs, quality manuals, work instructions, and complete QMS builds. ISO 9001/27001/42001 from gap assessment through certification readiness. Audit preparation, corrective action workflows, and management review packages. Rebuilt an entire QMS for a global clinical trials platform, zero audit findings across dual ISO certification. Privacy Policies, Terms of Service, and Legal Compliance Documents. GDPR-compliant privacy policies, terms of service, cookie policies, data processing agreements, sub-processor agreements, consent frameworks, and data subject rights implementation. Fixed 7 live GDPR violations for an AI meeting platform. Built Django deletion workflows for right-to-erasure compliance. Global consent matrices covering US, EU, Canada, and Asia-Pacific. FDA and Medical Device. Form 483 responses, quality system reconstruction, Design History Files, ISO 14971 risk management, CAPA programs, design control, complaint handling, and medical device reporting. 21 CFR Part 11 and QMSR. Financial Services and Operational Resilience. Business continuity and IT disaster recovery frameworks for U.S. financial institutions. Operational resilience programs aligned with OCC, FDIC, FRB, and FFIEC guidance. SR 11-7 model risk status assessments. Regulatory framework mapping for banking and fintech compliance. AI Compliance and Risk Frameworks. EU AI Act roadmaps. ISO 42001. NIST AI RMF. HIPAA Security Risk Analyses. Privacy impact assessments for GDPR, CCPA, and state AI laws. GxP validation and 21 CFR Part 11 compliance for healthcare AI. CURRENT AND RECENT WORK FDA 483 Response and Quality System Reconstruction. Form 483 response filed ahead of the agency deadline for a Class II medical device manufacturer, followed by a complete quality system rebuilt from zero. Quality Manual, six core SOPs, CAPA package, design control, complaint handling, medical device reporting, and device history records. Every deliverable traced to the investigator's citations and verified against QMSR primary text. ISO 27001:2022 Certification Program. Full certification preparation for a medical diagnostics informatics platform. Gap assessment, a fourteen-document ISMS, tiered implementation register, and a risk register with likelihood scored against the organization's own incident record. HIPAA Security Rule Rationalization. A compliance platform generated a 272-item HIPAA Security assessment for a managed service provider. The rule contains 65 requirements. Rebuilt to all 65, consolidated into 15 workable questions, with a crosswalk mapping each back to its exact citation and audited against eCFR. Multi-Entity Financial Services Governance. Regulatory gap assessment and phased remediation program for a multi-entity fintech group, delivered through outside counsel. 35 findings across 10 governance domains, mapped to 13 frameworks and a multi-state applicability survey. Health Data Privacy, International Expansion. Cross-border transfer instruments, DPIA, records of processing, and participant consent architecture for a health research platform expanding into Egypt and Albania. GDPR, Egypt PDPL, and Albania Law 9887. National AI Governance Framework. Developed the AI Governance Framework for the Republic of Liberia, integrating NIST AI RMF, OECD, UNESCO, EU AI Act, and African Union standards. Government-level deployment with training packages, implementation roadmaps, and stakeholder consultation. Enterprise Governance Platform Advisory. Independent strategic advisory to a governance and assurance platform on enterprise category positioning, adoption, and certification pathway, working with the executive team and board. GDPR Controller Determination. Corrected a controller-versus-processor misclassification for an AI clinical platform under GDPR Article 4(8), reassigning data protection obligations to the right party. THE FOUNDATION 27 years in regulated industries. Fortune 500: Alcon/Novartis (8 years, 200+ projects), Gilead, Genzyme, Pfizer, Baxter, Eli Lilly. Zero audit findings. Consent decree and FDA regulatory action leadership. MS Operations and Project Management. PMP certified 20 years. Contributing author, The FDA Group Newsletter (10,000+ executives). Author of four books on compliance and AI governance. 300+ templates covering EU AI Act, ISO 42001, NIST AI RMF, ISO 27001