---
title: 003
description: A consultant with The FDA Group.
---

[The FDA Group's Consultant Finder ](https://www.thefdagroup.com/find-consultants)

# [003](https://www.thefdagroup.com/find-consultants/003)

 Written by [The FDA Group](https://www.thefdagroup.com/find-consultants/author/the-fda-group) | Mar 10, 2022 4:11:14 PM

**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.

[View full post](https://www.thefdagroup.com/find-consultants/003)

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