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Consumer Safety Officer, (CBER/OCBQ) Resume Example

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CONSUMER SAFETY OFFICER, (CBER/OCBQ)
Profile

Over 18 years of experience at the FDA in multiple disciplines. Accomplished and results driven professional with expertise as a Consumer Safety Officer seeking a challenging position to contribute to the employer's further success

Skills
  • Quality Assurance
  • Lot Release
  • Healthcare Administration
  • Regulatory Compliance
  • Project Management
  • Medical Devices
  • Cardiovascular Devices
  • FDA Biologics Law
  • Situational Analysis
Accomplishments

Detail oriented and proficient problem solver with strong analytical skills to evaluate risks and remediation strategies. Influential team-player and communicator with a strong with a strong project management and leadership track record. Highly skilled at managing product Lot Release and advisory of FDCA regarding regulatory compliance. Developed and implemented policies and procedures in collaboration with manufacturers and other internal and external stakeholders to improve product quality compliance. Drafted and presented SOPP documents and plans for meetings, conferences, and negotiations. Collaborated the resolutions to technical regulatory compliance issues and standard operating procedures.

Professional Experience
Consumer Safety Officer, (CBER/OCBQ), 07/2006 to CurrentUnited States Food and Drug Administration FDA - Rockville, MD
  • Establish and review protocols and procedures to process sample receipt from manufacturers in support of their request for product approval, surveillance, licensing, and other applications.
  • Manage staff, resources, and work flow assignments.
  • Review sample protocols for completeness and accuracy,, perform the final review of Surveillance protocols and coordinate the receipt of samples. Process lot submissions for specialized products like IVD test kits; process initial protocol and generate initial sample request; manage final Actions for Lot Release and process Release Notifications.
  • Draft quantitative and qualitative analysis reports and recommendations, advising manufacturer and management of results; review compliance documents and report recommendations.
  • Perform quality assurance reviews.
  • Support enforcement action for other CBER or field components.
  • Collaborate with the following product offices: Office of Blood and Regulatory Review (OBRR) on reviews, lot releases.
  • Collaborate with the following OCBQ Divisions: Division of Case Management (DCM), Division of Inspections and Surveillance (DIS) and Division of Biological Standard and Quality Control (DBSQC).
  • Provide QA technical consultation in the Product quality and disposition of deviations and best practices.
  • Improve Batch Record, QA data management systems to ensure cGMP compliance.
  • Provide guidance on regulatory compliance to manufacturer.
  • Coordinated meeting with originators for purpose of clarification and resolution of inconsistencies
  • Manage the classification of correction and removal of a FDA regulated product
  • Implement comments on proposed policies and issuances as they impact FDA mission; coordinated the review of Establishment Inspection Reports; prepared written statements utilized by lead investigators
  • Served as an office representative on matters related to OIR Medical Devices
  • Advised officials and consumers on enforcement policies, methods, and interpretation of regulations
  • Led research medical device specific regulatory documents
Consumer Safety Officer, (CDRH/OIR)-(Detail), 08/2014 to 12/2014United States Food and Drug Administration - Rockville, MD
  • Initiated regulatory action against manufacturer that they are not in good CGP compliance.Initiated discussion / meeting with originators for purpose of clarification and resolution of in consistencies.
  • Coordinated the classification of a firm's correction and / or removal of a violative FDA regulated product.
  • Developed written material reflect policy, philosophy and accomplishments.
  • Drafted comments on proposed policies and issuances prepared by other components as they may impact on FDA mission.
  • Served as an office/organizational representative on all matters related to OIR Medical Devices.
  • Advised industry, state and local officials as well as consumers on enforcement policies, methods, and interpretation of regulations.
  • Coordinated the review of Establishment Inspection Reports.
  • Reviewed the design control and manufacturing documentation for premarket approval applications.
  • Researched, abstracted and reviewed medical device specific regulatory documents.
  • Organized and prepared written statements to be utilized by lead investigators when presenting to committee panels. Managed and investigated FDA regulated product complaints.
Consumer Safety Technician, (CDRH/ODE), 01/2001 to 07/2006United States Food and Drug Administration - Rockville, MD
  • Directed activity in the administration and processing of regulatory submissions for the Circulatory Support and Prosthetics Branch, and the Interventional Cardiology Devices Branch.
  • Lead, Prepared FOI requests, including researching files in IMAGE and the document mail center, including responding to industry inquiries regarding status of files under review by the Agency.
  • Performed administrative-legal review of investigational device exemptions (IDES) and Premarket approval application (PMA) submissions after scientific review and prior to final endorsement by the Division Director.
  • Performed administrative review of all new premarket notification (510(K)s), IDEs and PMA received in the Division to determine if pertinent information has been submitted.
  • Interpreted and applied federal guidelines and policies.
  • Assembled background information before routing mail and notifies supervisor of pending delays and their reasons.
  • Applied specific, detailed scientific or regulatory information from various sources for evaluation or reporting purposes.
  • Lead in the preparation and assembly of technical and regulatory information, documents and reports for presentation.
  • Managed work-flow of organization.
  • Revised files to meet current needs and personally reviews material for disposition.
  • Reviewed the status of pending case files and advises on delinquent information and data still required.
  • Reviewed routine device submissions, supplements and amendments to ensure they comply with regulatory requirements.
Project Management, (CDRH/OSB) - (Detail), 02/2006 to 06/2006United States Food and Drug Administration - Rockville, MD
  • Constructed case history files of approved LASIK lasers by evaluating specific data in PMA applications, tracking the PMA data to their corresponding questions in IDE application, and compiling the data.
Project Management, (CDRH/OSB)-(Detail), 02/2006 to 06/2006MedSun Pediatric Labeling Compendium - Rockville, MD
  • Worked with OSB's Patient Safety Staff on the Pediatric Labeling Compendium Project.
  • The project was a major part of MedSun's 2006 outreach efforts to provide feedback for device users, specifically to pediatricians and pediatric practitioners within the clinical community on indications for medical device use in pediatric populations.
Program Analyst, (CDRH/OC)-(Detail), 11/2002 to 12/2002United States Food and Drug Administration - Rockville, MD
  • Provided support to the Medical Device Registration and Listing Program under the direction of Special Assistant to the Office Director.
  • Analyzed registration and listing precedence files inventory, including mail out of letters and completing phone calls to verify whether individuals are aware they are an agent for a specific company as part of the U.S. agent audit program.
Administrative Officer, (CDER), 02/2000 to 01/2001United States Food and Drug Administration - Rockville, MD
  • Controlled and tracked Abbreviated New Drug Application (ANDAs) including arrangement of spreadsheets/graphics within many computer software packages.
  • Oracle based proprietary program: BIMS, DLS, DATS, Microsoft Word and Team links Information.
  • Traced FDA regulatory documents.
  • Signed technical and non-technical letter for the supervisor, as appropriate, after the draft been approved.
  • Reviewed and controlled outgoing correspondence and action documents relating to response and inquiries from the general public, contractors, manufacturers associations, manufacturers etc prior to signature for the proper format.
  • Developed systems to analyze highly visible actions such as legislation, executive.
  • Developed written products including goals, budgets, and plan to improve program operations.
  • Reviewed and critiqued staff works in a constructive and substantive manner to ensure accuracy for leadership to ensure accuracy for leadership action.
  • Analyzed and interpreted program data for preparation of briefing materials and reports.
Senior Training Specialist, 12/1994 to 01/2000PSI International, Inc - Rockville, MD
  • Trained and supervised new employees in archiving licensed and approved documents Medical Device Files, 510K, IDE, NDA.
  • Originator, writer, and coordinator of Standard Operating Procedures (SOPs) for the entering and storage of documents in the database.
  • Provideed technical support and documentation for meetings of Consumer Safety Officers, Medical Officers and CDER reviewers with regulated industry.
  • Compilation of the documents of final actions: acknowledgment letters, complete review letters, approvals and withdrawals.
  • Provided status reports on document searches for previous applications, supplements, and Freedom of Information Act (FOIA) inquiries and requests.
Education and Training
Bachelor of Science:Health Care Administration,1994Columbia Union College. MD

Health Care Administration

FDA Training
  • Laboratory Safety
  • Introduction to Epidemiology
  • Improving your Project Management Skills
  • CBER Medical Device Reviewer
  • Biologics Law
  • New Reviewer Introduction to CMC Review & Analytical Methods Development & Validation
  • AHA Healthcare Provider (CPR)
  • The Art of Communication
  • Introduction to Bioethics
  • Designing Cardiovascular Devices
  • Reviewing & Editing the Writing of Others
  • Medical Device Law
Technical Skills and Qualifications

Microsoft Office Suite, Outlook, Access, Unicorn, Microsoft Project, EAMS, and very adaptable to learning specific on the job computer systems. Fluent in Farsi/Persian and Turkish.


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Resume Overview

Companies Worked For:

  • United States Food and Drug Administration FDA
  • United States Food and Drug Administration
  • MedSun Pediatric Labeling Compendium
  • PSI International, Inc

School Attended

  • Columbia Union College. MD

Job Titles Held:

  • Consumer Safety Officer, (CBER/OCBQ)
  • Consumer Safety Officer, (CDRH/OIR)-(Detail)
  • Consumer Safety Technician, (CDRH/ODE)
  • Project Management, (CDRH/OSB) - (Detail)
  • Project Management, (CDRH/OSB)-(Detail)
  • Program Analyst, (CDRH/OC)-(Detail)
  • Administrative Officer, (CDER)
  • Senior Training Specialist

Degrees

  • Bachelor of Science : Health Care Administration , 1994

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