Lisa Lopez

Lisa Lopez Email and Phone Number

Saint Paul, MN, US
Lisa Lopez's Location
Greater Minneapolis-St. Paul Area, United States
Lisa Lopez's Contact Details

Lisa Lopez work email

Lisa Lopez personal email

n/a
About Lisa Lopez

Manager with more than 30 years of experience in quality systems and regulatory affairs within and outside FDA. Operational knowledge covers the whole spectrum of FDA regulated commodities. Strong computer and communication skills in English and Spanish. Top strengths per Gallup StrengthsFinder Assessment: Strategic, Achiever, Learner, Responsibility and Activator.

Lisa Lopez's Current Company Details
Profesional independiente

Profesional Independiente

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Retired
Saint Paul, MN, US
Lisa Lopez Work Experience Details
  • Profesional Independiente
    Retired
    Profesional Independiente
    Saint Paul, Mn, Us
  • Fda
    Supervisory Consumer Safety Officer -- Ora-Wide Qms Programs
    Fda Jul 2014 - Present
    United States
    Currently serving as the QMS Director for ORA in the Office of Strategic Planning and Quality Management. Have served in a variety of roles such a Program Manager, Deputy Director and Chief.
  • Fda
    Assistant Regional Director -- Latin America Regional Office
    Fda Feb 2009 - Jun 2014
    San Jose, Costa Rica
    Represented the US FDA in interactions with international organizations, foreign regulatory authorities and other foreign government entities and industry throughout Latin America. Served as Diplomat (Attaché) assigned to the US Embassy in San Jose, Costa Rica for the US FDA Latin America Office from August 2009-June 2014. Member of the Embassy's Quality Team. Led the negotiations that resulted to Costa Rica's recognition of FDA's approval and clearance of medical devices.Planned, managed and coordinated multiple outreach programs throughout the region. Served in multiple details as Deputy Regional Director and Regional Director.
  • Fda
    Supervisory Consumer Safety Officer/Consumer Safety Officer
    Fda Mar 2000 - Feb 2009
    Minneapolis, San Juan And Dallas Districts
    Served as Investigator, Supervisory Investigator and Acting Director of Investigations. Also served in multiple functions such as:Drug Program ManagerBioresearch Monitoring (BIMO) Program ManagerImports Program ManagerDietary Supplements Program CoordinatorProfile CoordinatorNew Hire Training CoordinatorPre-approval ManagerInternal Quality Auditor Champion of the ORA Revitalization QMS Training sub-group Official Establishment Inventory Coordinator
  • Pack Logix, Inc. (Formerly Panef Corporation)
    Director Of Quality And Regulatory Affairs
    Pack Logix, Inc. (Formerly Panef Corporation) Oct 1998 - Mar 2000
    Milwaukee, Wisconsin
  • Triad Group
    Laboratory Director
    Triad Group Aug 1998 - Sep 1998
  • Matarah Industries (Purchased By Athea Laboratories In 2001)
    Quality Assurance/Regulatory Affairs Manager
    Matarah Industries (Purchased By Athea Laboratories In 2001) Oct 1996 - Jul 1998
    Milwaukee, Wisconsin
  • Mc Neil Consumer Products Co
    Quality Control Laboratory Technician
    Mc Neil Consumer Products Co Jan 1992 - Jun 1992

Lisa Lopez Skills

Government Strategic Planning Program Management Leadership Data Analysis Training Management Project Management Quality Assurance Strategy Risk Management Process Improvement Operating Budgets Six Sigma Regulatory Affairs Medical Devices Pharmaceutical Industry Haccp Capa Iso 13485 Fda Gmp International Trade Auditing Regulatory Requirements Quality Management Cross Functional Team Leadership Corrective And Preventive Action

Lisa Lopez Education Details

Frequently Asked Questions about Lisa Lopez

What company does Lisa Lopez work for?

Lisa Lopez works for Profesional Independiente

What is Lisa Lopez's role at the current company?

Lisa Lopez's current role is Retired.

What is Lisa Lopez's email address?

Lisa Lopez's email address is li****@****fda.gov

What schools did Lisa Lopez attend?

Lisa Lopez attended University Of Wisconsin, Tecnológico De Costa Rica, Universidad De Puerto Rico.

What skills is Lisa Lopez known for?

Lisa Lopez has skills like Government, Strategic Planning, Program Management, Leadership, Data Analysis, Training, Management, Project Management, Quality Assurance, Strategy, Risk Management, Process Improvement.

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