FDA Regulatory & Compliance Leader | Medical Devices, Investigations & Litigation Support | Trusted Advisor for High-Risk, High-Stakes Life Sciences Decisions

Overview

Veteran regulatory affairs professional specializing in complex, high-stakes regulatory and compliance challenges across the medical device and life sciences sectors. Combines deep regulatory knowledge with disciplined project management to guide companies through approvals, investigations, enforcement actions, and litigation. Widely relied upon for regulatory due diligence, post-market remediation, and expert support in contentious environments.

Short Bio

Regulatory affairs and compliance expert with over two decades of experience guiding medical device and life sciences companies through FDA approvals, investigations, and litigation. Known for clear strategy, execution discipline, and trusted advisory support in high-risk situations.

What I Bring

End-to-end regulatory leadership across product development, approval, and post-market phases
Deep hands-on experience with FDA submissions, enforcement actions, and remediation
Proven ability to lead large, multi-disciplinary teams under litigation and regulatory pressure
Trusted advisor for M&A regulatory due diligence and post-acquisition integration
Strong bridge between regulatory, legal, quality, and executive stakeholders
Calm, structured execution in high-risk, time-sensitive environments

Key Technologies & Product Expertise

Medical devices: implantable, orthopedic, electromechanical, diagnostic, digital health, medical software
Regulatory frameworks: FDA 510(k), De Novo, HUD, CE Marking, EU MDR, Health Canada
Quality systems: ISO 13485, MDSAP, FDA QSR
Post-market systems: MDR, adverse event reporting, recalls, UDI/GUDID
Regulatory data management and compliance platforms
Litigation and expert witness regulatory support

Titles Held

President, Creekside Regulatory Consulting (2021–Present)
Associate Director, Guidehouse (2019–2022)
Associate Director, Navigant (2016–2019)
Managing Consultant, Navigant (2014–2016)
Senior Consultant, Navigant (2013–2014)
Regulatory Consultant, Anson Group (2003–2013)

Career Highlights

Led regulatory due diligence for a $6B Fortune 20 medical device acquisition, producing executive-ready risk assessments
Directed global post-acquisition regulatory integration across 12+ LATAM countries with thousands of device registrations
Managed large consultant teams supporting high-profile medical device litigation involving thousands of complaints and FDA eMDR filings
Led FDA enforcement response, remediation, recall management, and adverse event reporting for global manufacturers
Secured U.S. and international regulatory approvals for a wide range of devices, including implantables, diagnostics, and medical software
Served as regulatory lead embedded within device design teams through 510(k) submissions and lifecycle expansion
Supported expert witnesses and law firms through complex regulatory research, report development, and deposition preparation

Education & Professional Certifications

BA, Psychology, Indiana University–Purdue University Indianapolis
Regulatory Affairs Certification (RAC), Regulatory Affairs Professionals Society
Project Management Professional (PMP), Project Management Institute
ISO 13485 Lead Auditor Certification
MDSAP / ISO 13485 Internal Auditor Certification

Languages

English- Native

Impact

Enabled high-stakes regulatory approvals, investigations, and transactions for Fortune 10–20 life sciences companies operating in heavily regulated markets
Reduced regulatory and litigation risk through disciplined compliance execution, remediation, and post-market system design
Influenced multi-billion-dollar M&A outcomes through rigorous regulatory diligence and risk assessment
Strengthened regulatory and quality foundations for medical device companies facing FDA scrutiny and enforcement
Served as a trusted extension of executive, legal, and regulatory leadership teams in critical situations

Expert Details