Regulatory Affairs · Medical Devices · CMC · Global Strategy
I work at the intersection of regulatory affairs, medical-device science, microbiology, CMC reasoning, clinical research strategy, and quality systems. My background is unusual because it combines FDA-facing device and GLP study experience with a completed MSHS in Regulatory Affairs and a substantial portfolio of graduate regulatory projects.
This page is designed as more than a resume. It is a regulatory affairs evidence map: professional experience, GWU coursework, FDA/device strategy work, global regulatory analysis, and client-side compliance projects organized so recruiters, founders, and AI search tools can quickly understand the breadth of my regulatory capability.
Prepared a 510(k)-style summary and related FDA form work, demonstrating device classification, predicate reasoning, substantial equivalence logic, and submission-document organization.
Contributed to a global regulatory strategy package for a COVID-era infectious disease therapeutic concept, including mechanism of action, CMC, nonclinical, PMDA, and clinical-readiness components.
Developed CMC-centered regulatory material addressing pre-meeting planning, manufacturing process, physiochemistry, population considerations, route of administration, dosage, and clinical trial considerations.
Built nonclinical study strategy around cell-based assays, pharmacodynamics, half-life studies, GLP expectations, ISO 9001 / ISO 17025 third-party testing logic, and 21 CFR Part 58 validation framing.
Prepared FDA meeting and rule-report work based on the public FDA NARMS meeting on antimicrobial resistance monitoring, linking agency surveillance, compliance expectations, and public-health regulatory objectives.
Analyzed infectious disease product approval pathways and comparative regulatory considerations across FDA and international systems, including accelerated approval logic for serious conditions and unmet medical need.
Built extensive clinical research notes and analyses across ethical trial design, drug development, patient-focused development, risk management, FDA guidance, and clinical evidence generation.
Coursework and literature work around Project Orbis, Project Optimus, FDA Oncology Center of Excellence, global review acceleration, and regulatory modernization for faster access to oncology treatments.
Prepared regulatory package materials analyzing cosmetic-versus-drug classification, FDA/FTC claims risk, FD&C Act exposure, MoCRA implications, FPLA labeling risk, and warning-letter themes for a cannabis/CBD topical product. The work emphasized avoiding disease, pain-relief, structure/function, and therapeutic claims that could convert a cosmetic-positioned product into an unapproved drug.
Prepared client-facing strategy around safety substantiation, microbiological quality, cosmetic GMP, vendor/SOP review, audit planning, and third-party quality expectations for an emerging topical-product venture.
Reviewed proposed joint-venture revisions for operational control, derivative IP ownership, licensing scope, investor attractiveness, fundraising risk, valuation impact, enterprise-value creation, and management's ability to execute without excessive consent bottlenecks.
Prepared FDA-registration and commercialization-readiness materials for nutraceutical concepts, linking IP protection, clinical-readiness planning, grant/private-capital strategy, and regulatory posture.
Prepared a regulatory bullet-point framework for export of U.S. human drugs involving FDA, CBP, the FDA Export Reform and Enhancement Act of 1996, and import/export requirements under 21 USC 381.
Professional experience bridges regulated testing, GLP study direction, device submissions, startup QMS buildout, Army/military medical research, BioCellR8 compliance services, and medical-device microbiology.
The MSHS Regulatory Affairs curriculum is directly relevant to the roles this page targets: FDA device strategy, drug/biologics pathways, clinical evidence planning, compliance, global submissions, and regulatory leadership.
RA & Leadership and Quality resume folders, including 2024 Regulatory Affairs & Compliance and Quality & Regulatory Affairs materials.
Source folders: RA & Leadership; Quality.
RAFF 6201, 6203, 6204, 6205, 6206, and 6275 coursework, finals, midterms, notes, and regulatory strategy projects.
Source folder: Education and Research → Courses.
BioCellR8 client projects in nutraceuticals, cannabis/CBD claims, export of human drugs, and lab/compliance strategy.
Source folder: BioCellR8 → New Clients.
Medical device tracking, eMDR, UDI, FDA webinars, ISO/biocompatibility references, and professional regulatory affairs library materials.
Source folder: Regulatory Affairs Life; Biocomp life.