Jack B. Brown
30 Years FDA Regulatory & QA Expertise | 510k, PMA, QMS, Audits | Radiology, IVD, Orthopedic
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 core competencies lie in developing and implementing robust quality management systems (QMS), leading comprehensive internal and external audits, and providing strategic oversight for critical processes such as CAPA, investigations, and change control. He is highly skilled in preparing and submitting essential regulatory documents for product approvals, including 510(k), IDE, and PMA applications, and adeptly manages interactions with regulatory agencies. Furthermore, Jack excels in building and mentoring high-performing QA teams, cultivating a strong culture of quality and accountability.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), PMA
Device Types Supported:
IVD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
30
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
radiology, ivd, orthopedic
Engagement Models:
hourly
Accepting New Clients:
Yes
