Charles Chacko
Frisco
Summary
Federal regulatory compliance officer with expertise in quality assurance and regulatory affairs. Proven track record in interpreting complex regulations and executing effective compliance strategies. Enhanced industry auditing processes while addressing compliance challenges and delivering exceptional customer service.
Overview
24
24
years of professional experience
Work History
Regulatory Compliance Officer
U.S. Food and Drug Administration
Silver Spring
11.2015 - Current
- Reviewed and evaluated evidence indicating potential non-compliance with agency-enforced laws and regulations, leading to informed decision-making.
- Determined the most suitable course of action and recommended legal actions to subject matter experts at Headquarters and the Office of the Chief Counsel.
- Required non-compliant establishments to make necessary changes to meet the regulations.
- Collaborated with industry representatives to exchange critical information and provide targeted guidance on addressing public health deficiencies.
- Performed analyses and evaluations on data samples and documented information gathered during inspections and investigations.
- Interacted with various levels of officials representing the firm’s subjects to regulatory review.
- Answered inquiries from other Federal, State, or Local Agencies regarding interpretations of Agency-enforced laws and regulations, case status, and enforcement policies.
- Designed and implemented training programs to enhance understanding of compliance activities among staff, fostering a culture of regulatory adherence.
- Analyzed study results, and whether an investigation is complete.
- Acted as the Director of the Compliance Branch when requested.
Consumer Safety Officer (Investigator)
U.S. Food and Drug Administration
Parsippany
09.2008 - 11.2015
- Conducted comprehensive inspection of domestic and international medical device and diagnostic manufacturers to assess compliance with appropriate FDA regulations, such as the QSR, Medical Device Reporting (MDR) regulations, 21 CFR Part 11, 510(k) Pre-market Notification regulations and Pre-market Approval regulations.
- Conducted inspections of foreign medical device manufacturers to determine compliance with U.S. regulations for products imported into the United States.
- Inspections at establishment in violation of FDA regulations have required extensive evidence development and documentation, including report writing, and have resulted in regulatory actions such as warning letters, seizures and injunctions.
- Inspected contract sterilization facilities to ensure compliance with safety protocols for ethylene oxide, gamma radiation, and electron beam radiation.
- Communicated violative inspectional findings to various levels of New Jersey District and FDA Center management, including Investigations Branch Director, Compliance Branch Director, and Center for Device and Radiological Health (CDRH) Unit Directors.
- Advised and collaborated with officials at various levels to facilitate compliance and address regulatory issues in establishments under review.
- Contacted industry officials to gather incomplete regulatory and scientific information and discuss investigation statuses, ensuring thorough documentation and transparency.
- Provided on-the-job training to lower-graded trainees on sophisticated techniques used in establishment inspections and investigations.
- Recipient of multiple Food and Drug Administration’s Group Recognition Awards for outstanding accomplishments in conducting inspections.
R&D Documentation Specialist
Barr Laboratories, Inc, Teva Pharmaceuticals
Pomona
02.2008 - 09.2008
- Developed and reviewed Master Batch Manufacturing Records (MBMRs) for Generic Drugs, ensuring compliance with regulatory standards.
- Initiated Production Process Change Control activities in GX Pharma to enhance operational efficiency.
- Created checklist procedures for R&D training program to standardize training and improve onboarding.
Medical Documentation/Software Specialist
SIEMENS Healthcare Diagnostics
Tarrytown
02.2007 - 02.2008
- Developed and reported software specification test cases for successful release of ADVIA A2400 Chemistry Software v3.00.03e and A1800 Chemistry Software v1.01.01.
- Conducted software verification and validation testing for clinical and integrated chemistry analyzers, ensuring compliance with SVT group standards.
- Executed acceptance testing for Commercial Off-The-Shelf (COTS) products to validate functionality and reliability.
- Performed identification, documentation, evaluation, segregation, and disposition of nonconforming issues and data entry into the DevTrack System.
Medical Technologist
Quest Diagnostics
Teterboro
10.2006 - 02.2007
- Executed Free Testosterone diagnostic testing using Enzyme Immunoassay (EIA) on liquid scintillation counters (TRI-CARB Model 2200CA) to ensure accurate hormone level assessments.
- Performed Total Testosterone diagnostic testing by Equilibrium Dialysis, and Chemiluminescence’s Method on
- (Bayer Advia Centaur) and Gamma Counter (GENESYS).
- Performed quality control and parallel studies on various controls, calibrators, and reagents to maintain compliance and ensure test accuracy.
- Performed cGMP analysis, documentation, and review of data/documents and data entry to host terminals.
- Supported pipetting and vial transfer processes in the Methylmalonyl Acid laboratory environment.
Medical Technologist
Bio Reference Laboratories
Elmwood Park
03.2005 - 10.2006
- Conducted preliminary analytical screening tests for drugs of abuse using Cobas Integra 700 and Hitachi Modular P800, contributing to accurate detection.
- Ensured accuracy and reliability of screening quality controls, calibrators, and reagents through stringent quality control procedures, maintaining testing integrity.
- Executed Linearity Studies for drugs of abuse and performed validations and correlations for new techniques, enhancing testing protocols.
- Performed confirmed analytical results on GC/MS.
- Performed cGMP analysis, documentation, and review of data/documents and data entry to host terminals.
Lab Tech Assistant/Research Student
University of Medicine and Dentistry (UMDNJ)
Newark
01.2002 - 09.2002
- Executed DNA/RNA sequencing and synthesis reactions to facilitate genetic analysis.
- Generated sequence data, performing data analysis and delivery.
- Performed Fragment Analysis and Typhoon Imager scanning fluorescence and chemiluminescence’s materials.
- Supported scientists in developing and implementing molecular techniques and research strategies.
- Performed research projects dealing with Immunological methods.
- Managed supply orders and maintained daily inventory logs for laboratory chemicals.
Education
Bachelor of Arts - Biology, Chemistry
Rutgers, The State University of New Jersey
Newark, NJ12-2004
Skills
- Regulatory compliance
- Regulatory documentation
- Regulation enforcement
- Compliance frameworks
- Compliance procedures
- Quality assurance
- Quality auditing techniques
- ISO standards expertise
- AAMI and ANSI
- Analytical validation
- Risk assessment
- Audit methodology
- QSR and QMSR knowledge
- Regulatory reporting
- Critical thinking
- Analytical
- Team collaboration
- Microsoft Word
- Excel
- PowerPoint
- Access
- Modeling software
- Visual documentation
- Web compliance
- Digital communication
- Graphic design
- Interactive media
- Excellent communication
- Digital communication
Awards
- Received FDA Group Recognition award by Dr. Margret Hamburg, FDA Commissioner in Salmonella Montevideo Outbreak resulting in recalls of adulterated products and protection of public health.
- Received FDA Group Recognition award in the areas of OTC drug products, medical devices, dietary supplements, food inspections, and Hurricane Sandy agency response.
- Certificates of Appreciation for recognition for exceptional services in performing duties of a Compliance officer.
References
References are available upon request.
Technical Skills
HPLC purifications & separation (Varian Prostar HPLC), Atomic Absorption Spectroscopy (AAS), Anodic Stripping Voltammetry (ASV), GCMS, Re-crystallization, Melting Points, Distillation, Extractions, Drying tubes and drying agents, Refractive index, Infrared spectroscopy, Northern and Southern Blots, SDS gels, PCR, Microsoft Word, Excel, PowerPoint, Access, Windows XP/2000/98, AutoCad 13/14, 3D Studio, Photoshop 5.5/7.0, Adobe Illustrator, Flash 4,5, HTML 3.0, FrontPage, Internet
Coursework
- General Biology I & II
- General Chemistry I & II
- Foundations of Biology
- Animal Ecology
- Molecular Biology
- Organic Chemistry I & II
- Immunology
- Comparative Anatomy
- Physiology
- Physical Chemistry
- Analytical Chemistry
- Pathophysiology
- Pharmacology for PT
- Clinical Trials
- Biomedical Informatics
- Calculus I
Languages
Arabic
Elementary
Hindi
Limited
Malayalam
Professional
Affiliations
- Volunteer, Denton County Juvenile Detention Center - Denton, TX (March 2024 - Present)
Accomplishments
- FDA Center Director Special Citation Award, September 11, 2025 - For ensuring the successful implementation of FDA reorganization activities impacting the medical device and radiological health program.
- Group Recognition Award, July 18, 2023 - Recognition of regulatory action taken against a large, multiple-commodity filthy warehouse resulting in multi-million dollar recall, and closure of the warehouse.
- Group Recognition Award, August 09, 2021 - A Day in the Life Educational Series Work Group to enhance both internal and external stakeholder relationships by highlighting key roles
- Leveraging/Collaboration Award, August 09, 2021 - Emergency Response associated with the COVID-19 Pandemic.
Timeline
Regulatory Compliance Officer
U.S. Food and Drug Administration
11.2015 - Current
Consumer Safety Officer (Investigator)
U.S. Food and Drug Administration
09.2008 - 11.2015
R&D Documentation Specialist
Barr Laboratories, Inc, Teva Pharmaceuticals
02.2008 - 09.2008
Medical Documentation/Software Specialist
SIEMENS Healthcare Diagnostics
02.2007 - 02.2008
Medical Technologist
Quest Diagnostics
10.2006 - 02.2007
Medical Technologist
Bio Reference Laboratories
03.2005 - 10.2006
Lab Tech Assistant/Research Student
University of Medicine and Dentistry (UMDNJ)
01.2002 - 09.2002
Bachelor of Arts - Biology, Chemistry
Rutgers, The State University of New Jersey