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PROFESSIONAL BACKGROUND

25 Years of Experience

2016 - 2023

VICE PRESIDENT, MEDICAL DEVICE/COMBO PRODUCTS

I managed complex projects to ensure compliance and improvement in pharmaceutical, medical device, and combination product lifecycles for multinational companies. I advised clients on upgrading control measures and system capabilities and developed strategies to incorporate new technologies and services to enhance quality standards. I led teams and client projects, focusing on team building, HR leadership, and operational excellence. Additionally, I created and delivered presentations, training, and publications for both industry and clients. My work aimed to boost business expansion and compliance through tailored, sustainable solutions.

2011 - 2016

DIRECTOR, INVESTIGATIONS

I was the head of the Chicago District Investigations Branch of the US FDA's Office of Regulatory Affairs. I managed a team of over 70 employees and oversaw domestic and import programs, inspections, investigations, sample collections, and emergency response programs for FDA-regulated products. I also handled compliance cases to support agency administrative and legal actions. My responsibilities included directing international inspections and quarterly work plans, as well as preparing a branch budget aimed at minimizing costs. I played a key role in delivering successful multi-organizational projects, collaborating with entities such as Interpol, the Office of Criminal Investigations, DEA, and USDA. Additionally, I managed emergency operations for natural disasters, epidemiological outbreaks, and national special events such as NATO/G8.

2006 - 2011

SUPERVISORY INVESTIGATOR

I supervised a team of Investigators working with all regulated commodities. I reviewed their work for final disposition and/or recommendation for further compliance, administrative, and legal actions. I also mentored and coached new Investigators in proper investigative practices, case development, investigative interviewing, and compliance practices. Additionally, I provided leadership and oversight for the Medical Device and Center for Veterinary Medicine program areas. I successfully developed organizational work plans, met quarterly and annual performance goals, and maintained internal quality management standards. I provided instruction and training in medical devices through the Office of Regulatory Affairs training program for four years and worked closely with state and local governments, DEA, USDA, and US Customs.

2000 - 2006

MEDICAL DEVICE SPECIALIST/ INVESTIGATOR

As an Investigator/Medical Device Specialist I conducted inspections and investigations of highly complex medical devices, combination products, and pharmaceutical manufacturers worldwide. I developed strong compliance cases that led to Warning Letters, Seizures, and Injunctions. I also supported investigations in cosmetics, dietary supplements, veterinary medicine, biomonitoring programs, and imports.

AWARDS

Mexican Rice Response (Cross-Cutting)

Compounding Team

NATO Summit

Commissioner's Special Citation - Necrotizing Enterocolitis Group

ORA Mentoring Program Committee

Adulterated Chili Powder Seizure

Leveraging and Collaboration - ED Products Team

Adulterated Topical Antimicrobial

Outstanding Contribution to Basic Medical Device Course

Medical Device Consent Decree

Leveraging and Collaboration - Cronobacter Group

Tissue Residue Injunction

Center for Devices Special Recognition – GAMBRO

Leveraging and Collaboration - Medical Device Training Group

Outstanding Service Award - Triazine in Animal Feed

Botulinum Toxin Response

Pet Food and Animal Food Contamination Response

Commissioner's Special Citation - Liberty Shield

Commissioner's Special Citation - ORA Counterterrorism

Outstanding Service Award - Ephedrine Seizure Group.

Outstanding Service Award, United States Attorney's Office

TRAINING

United States Food and Drug Administration

Food, Drug & Cosmetic Act | Food and Drug Law | Evidence Development | Compliance Law I & II |

Medical Devices | Quality System Regulation | Industrial Sterilization | Process Validation | Pre-approval Inspections | Pharmaceuticals | Drug Manufacturing and Quality Control | Active Pharmaceutical Ingredient Manufacturing | Pre-approval Inspections | Foods | Basic Food GMP | Low Acid Canned Foods | Dietary Supplements | Foodborne Outbreaks | Nutrition Labeling | Food Safety Modernization | Feed Manufacturing | Tissue Residue | Management/Development | Supervisory Potential | FAME I - Leadership Skills | FAME II - Leadership Skills 2 | Personnel Practices for Managers (2006/2008/2011) | Emergency Response/Management | Incident Command for Single Resources and Initial Actions (200) | Incident Command System Overview (300) | NIMS/ICS Staff Training | Regional Incident Command and General Staff | ICS Position Specific, Incident Commander | ICS Position Specific, Planning Chief

 

American Management Association

Advanced Executive Leadership Program | Developing Executive Leadership | Advanced Leadership Communication Strategies | Leading with Emotional Intelligence | Situational Leadership II | Strategic Planning

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