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.
About
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.
Additional information
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Jack's extensive 30-year experience across diverse medical device classes and specialties, combined with his hands-on approach to QMS implementation and regulatory submissions, offers clients a comprehensive and practical solution for navigating the complexities of FDA compliance.
- **Ideal projects:** The ideal project for Jack would involve guiding a small to medium-sized medical device company through the 510(k) or PMA submission process for a Class II or Class III device in the radiology, IVD, or orthopedic fields. He is well-suited for companies needing assistance with establishing or improving their quality management systems (QMS) to meet FDA, ISO, and cGMP requirements. Companies seeking support in managing CAPA, investigations, and change control processes, or those requiring assistance with internal and external audits, would also benefit greatly from his expertise. His experience with clinical trials also makes him a good fit for companies in that stage.
- **Last analyzed:** Sun Dec 14 2025 01:11:00 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** 510k-traditional, qms, pma, clinical-trials, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** radiology, ivd, orthopedic, quality system implementation, quality management systems, clinical trials, risk management
- **Device panels:** radiology, ivd, orthopedic
- **Regulatory pathways:** 510k, pma, ide
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### **Additional information**
- Type: independent
- Years of experience: 30
- Location: United States
- Availability: available_now
- **Strength summary:** 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.
- **Unique value:** Jack's extensive 30-year experience across diverse medical device classes and specialties, combined with his hands-on approach to QMS implementation and regulatory submissions, offers clients a comprehensive and practical solution for navigating the complexities of FDA compliance.
- **Ideal projects:** The ideal project for Jack would involve guiding a small to medium-sized medical device company through the 510(k) or PMA submission process for a Class II or Class III device in the radiology, IVD, or orthopedic fields. He is well-suited for companies needing assistance with establishing or improving their quality management systems (QMS) to meet FDA, ISO, and cGMP requirements. Companies seeking support in managing CAPA, investigations, and change control processes, or those requiring assistance with internal and external audits, would also benefit greatly from his expertise. His experience with clinical trials also makes him a good fit for companies in that stage.
- **Last analyzed:** Sun Dec 14 2025 01:11:00 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** 510k-traditional, qms, pma, clinical-trials, international
- **Device classes:** class-i, class-ii, class-iii
- **Specialties:** radiology, ivd, orthopedic, quality system implementation, quality management systems, clinical trials, risk management
- **Device panels:** radiology, ivd, orthopedic
- **Regulatory pathways:** 510k, pma, ide
---
### **Additional information**
- Type: independent
- Years of experience: 30
- Location: United States
- Availability: available_now
HQ:
United States
Languages:
English
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
