TIMOTHY J. JOINER — Q-Sub & Post-market Consultant (IVD/Other)
Senior Quality Assurance & Regulatory Affairs Consultant
Highly accomplished Quality and Regulatory Affairs leader with over 25 years of global experience in the medical device, IVD, and combination product sectors. Proven expertise in developing, implementing, and scaling compliant Quality Management Systems (QMS) aligned with FDA and international standards. Skilled in leading global submissions, regulatory strategy, inspection readiness, and post-mar...
Experience: 26+ years
Submissions: 7 510(k), 1 De Novo, 1 PMA
Expertise & Specializations
Regulatory Pathways
Device Specialties
Regions Served
TIMOTHY J. JOINER provides regulatory consulting services to clients in:
Credentials & Recognition
Education & Credentials
Holds a Bachelor of Science in Microbiology from the University of Oklahoma, providing a strong scientific foundation for understanding complex medical devices and biological interactions. Further enhanced by a Certified Quality Auditor (CQA) certification from the American Society for Quality and a Six Sigma Yellow Belt from Underwriters Laboratories, demonstrating a commitment to quality principles and process improvement.
Certified Quality Auditor (CQA) by the American Society for Quality, demonstrating a dedication to professional standards in quality assurance. Holds a Six Sigma Yellow Belt, indicating an understanding of process improvement methodologies.
Certifications
American Society for Quality
Underwriters Laboratories
Professional Experience
A seasoned Quality and Regulatory Affairs leader with over 25 years of extensive experience directing global Quality Assurance functions across the medical device, IVD, and combination product sectors. Proven ability to build and lead high-performing, cross-functional teams in complex, multinational organizations. Expertise spans developing, implementing, and scaling compliant Quality Management Systems (QMS) aligned with FDA and international standards, driving continuous improvement, and ensuring regulatory readiness. Significant experience includes leading global submissions, managing post-M&A QMS harmonization, and overseeing quality integration for new product introductions.
Executive Summary
Professional Overview
Highly accomplished Quality and Regulatory Affairs leader with over 25 years of global experience in the medical device, IVD, and combination product sectors. Proven expertise in developing, implementing, and scaling compliant Quality Management Systems (QMS) aligned with FDA and international stand...
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
- Regions: US, EU, APAC, MEA
- Background: 26+ years of regulatory experience.
Cruxi view
With 26 years of distinguished global experience, Timothy J. Joiner offers a rare and powerful combination of deep expertise in both Quality Management Systems and Regulatory Affairs. He excels at guiding medtech companies through the entire product lifecycle, from initial regulatory strategy and Q-Submissions to successful 510(k), De Novo, and PMA filings. His proficiency with complex technologies like SaMD, combination products, and IVDs, coupled with his ability to scale compliant QMS for FDA, EU MDR, and MDSAP standards, makes him an invaluable strategic partner. Companies benefit from his proven ability to not only achieve market access but also to build robust, inspection-ready quality infrastructures that support sustainable growth.
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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