Jack B. Brown
Regulatory Affairs Consultant
Jack B. Brown is a distinguished regulatory affairs consultant with 30 years of extensive experience in quality assurance and regulatory affairs. He consistently achieves exceptional results in high-pressure environments, demonstrating a strong ability to manage multiple projects and diverse teams while rigorously adhering to stringent regulatory standards including FDA, cGMP, QSR, and ISO. Jack's...
Experience: 30+ years
Expertise & Specializations
Regulatory Pathways
Device Specialties
Executive Summary
Professional Overview
Jack B. Brown is a distinguished regulatory affairs consultant with 30 years of extensive experience in quality assurance and regulatory affairs. He consistently achieves exceptional results in high-pressure environments, demonstrating a strong ability to manage multiple projects and diverse teams w...
Core Specializations
Regulatory Pathways
Device Specialties
Services Offered
Quality management system development, gap analysis, and ISO 13485 certification support for medical device manufacturers.
Pre-inspection preparation, mock FDA audits, and readiness assessments to ensure compliance before official FDA inspections.
Risk management system development, risk analysis, and ISO 14971 compliance support for medical device risk management.
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
Quality management system design, implementation, and validation to meet FDA and ISO requirements.
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.
Cruxi Independent Snapshot
Best suited for
- • MedTech companies seeking expert regulatory guidance
Experience signals
- Background: 30+ years of regulatory experience.
Cruxi view
Jack B. Brown brings 30 years of experience in quality assurance and regulatory affairs, making him a valuable asset for medical device companies navigating complex regulatory landscapes. His expertise spans the entire product lifecycle, from developing and implementing QMS systems to preparing and submitting regulatory documents for product approvals, including 510(k), IDE, and PMA submissions. His experience managing internal and external audits, coupled with his ability to build and mentor QA teams, positions him as a strong leader in fostering a culture of quality and accountability. His experience covers Class I, II, and III devices across radiology, IVD, and orthopedic specialties.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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