Jason Shaw

Accomplished Quality & Regulatory Compliance leader with 20+ years of experience spanning pharmaceutical and medical device industries. I specialize in integrating drug and device quality systems, driving operations quality strategy, and leading regulatory compliance initiatives in FDA-regulated and ISO-certified environments.

What sets me apart: I leverage AI as a strategic thought partner for complex, high-stakes decision-making—using it not for task automation, but to enhance judgment, stress-test strategies, and navigate ambiguous regulatory challenges. While most professionals use AI for basic tasks, I use it to think at an executive level, particularly valuable in quality and compliance where decisions carry significant business and patient safety implications.

CORE EXPERTISE
• Pharmaceutical & Medical Device Quality System Integration (21 CFR 211, 21 CFR 820, ISO 13485)
• Operations Quality Planning & Strategy | Centers of Excellence Management
• Regulatory Intelligence & Emerging Regulation Implementation
• FDA Warning Letter Remediation & Health Authority Inspections
• Multi-Site Quality System Harmonization | MDSAP & Global Certification
• CAPA & Internal Audit Program Ownership | Supplier Quality Strategy
• M&A Quality Due Diligence (QARA) | eQMS Leadership (TrackWise CSO)
• AI-Augmented Strategic Analysis & Complex Problem-Solving

CAREER HIGHLIGHTS
✓ Led FDA Warning Letter remediation and 483 responses as primary quality representative
✓ Integrated pharmaceutical and device quality systems during $12.4B Baxter-Hillrom acquisition
✓ Achieved MDSAP certification for 5 sites with 0 findings
✓ Implemented risk-based supplier audit program eliminating 100+ audits annually
✓ Directed quality oversight for 400 suppliers across pharmaceutical API and device operations
✓ Served as Front Room Lead for multiple FDA inspections and notified body audits

INDUSTRY EXPERIENCE
Medical Devices: Cardiac monitoring, surgical instruments, molecular imaging, diagnostic equipment, SaMD
Pharmaceuticals: Sterile drug delivery, APIs, excipients, parenteral products

My unique background bridging pharmaceutical GMP and medical device QSR requirements—combined with AI strategic thinking capabilities—allows me to drive compliant, efficient operations across complex global organizations.

Progressive quality leadership roles at Abbott Laboratories, Baxter Healthcare, GE Healthcare, Siemens Healthineers, Richard Wolf, and currently iRhythm Technologies.

Open to strategic quality leadership opportunities where AI-enhanced decision-making drives competitive advantage.