Principal Regulatory Consultant & Former FDA Investigator

Summary

Experienced regulatory consultant with over 15 years in the biotech and medical device industries, specializing in FDA compliance, CAPA management, and quality system remediation. Recognized for expertise in FDA and ISO audits, supplier qualification, and regulatory compliance strategy. Skilled in training for FDA and ISO audits and preparing companies for FDA inspection readiness. Extensive experience working with multinational companies in regulatory affairs, quality systems development, and compliance auditing.

Key Areas of Expertise

  • Quality Systems Auditing and CAPA Management
  • FDA Compliance and Remediation
  • Regulatory Compliance for Medical Devices (ISO 13485, QSR)
  • Supplier Qualification and Facility Audits
  • FDA Pre-Market and Post-Market Submissions
  • Clinical Trial Design and Safety Analysis

Professional Experience

Principal Consultant 
Poway, CA | Feb 2007-Present

  • Conducted mock FDA inspections, gap assessments, and supplier qualification audits, preparing clients for FDA inspections and bringing quality systems into compliance.
  • Remediated quality systems, focusing on CAPA systems, complaint handling, MDR systems, and nonconforming product management.
  • Provided quality systems training and FDA/ISO audit preparation for medical device manufacturers.
  • Led large-scale MDR remediation projects, including filing over 2,500 MDRs for multinational clients.
  • Managed quality systems for OEM medical device manufacturers, overseeing CAPA, complaint handling, nonconforming product management, and quality system updates.
  • Conducted corporate compliance audits for multinational medical device manufacturers, including audits of manufacturing, distribution, and warehousing sites worldwide.

Manager, Regulatory and Clinical Affairs – Oculir, Inc.
Poway, CA | Jan 2006-Feb 2007

  • Established and maintained a comprehensive quality system for a startup medical device company, ensuring regulatory compliance.
  • Designed and implemented clinical trial protocols, performed safety analyses of prototype devices, and managed IRB approvals and subject recruitment for clinical trials.

Regulatory Affairs Manager – INOVA Diagnostics, Inc.
San Diego, CA | May 2003-Sept 2005

  • Directed regulatory compliance and managed interactions with FDA, USDA, Health Canada, EU Notified Bodies, and other regulatory agencies.
  • Led company through ISO certification and successful audits for ISO 13485 and Canadian Medical Device Regulations.
  • Oversaw internal and supplier audit functions, conducted training sessions on quality and regulatory topics, and managed a team of 10 auditors.

Investigator – U.S. Food and Drug Administration
Los Angeles, CA | Sept 1997-May 2003

  • Conducted FDA inspections of medical device manufacturers for adherence to Quality Systems Regulations (QSR), documented inspectional findings, and coordinated PMA and 510(k) inspection assignments.
  • Selected as a National Trainer for TurboEIR, trained new hires in medical device inspection techniques, and was part of the International Inspection Cadre.

Education
Bachelor of Science in Bioengineering, Minor in Writing
University of California, San Diego

Certifications and Training

  • Lead Auditor ISO 13485:2016 – BSI (June 2019)
  • Management Systems Auditing ISO 19011 – BSI (June 2019)
  • Canadian Medical Device Regulations (CMDR) Overview – AQS (Dec 2012)
  • FDA Quality Systems Inspection Technique (QSIT) – FDA (1999)
  • Numerous FDA and ISO training courses covering compliance, sterilization, validation, and audit techniques

Awards

  • National Partnership for Reinventing Government "Hammer Award" for QSIT Pilot
  • FDA Group Recognition Award for TurboEIR Pilot
  • FDA Outstanding Achievement Award
  • Eagle Scout

Publications and Presentations

  • Regularly conducts company-wide training sessions on regulatory and quality topics for clients and industry groups.

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