
Veronica Fleck Downen
Intern

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About me
Director, Regulatory Affairs at MCRA, LLC
Education

UNC Chapel Hill
2010 - 2014Bachelor of Science (B.S.) Biomedical EngineeringActivities and Societies: Hispanic Studies Minor, National Society of Leaderhsip and Success, All-Girl Club Cheerleading, Biomedical Engineering Club

The George Washington University School of Medicine and Health Sciences
2016 - 2018Masters of Health Science (M.S.) Health Professions and Related Clinical Sciences, Other
Experience

World Airways
Jun 2008 - Jul 2008Intern> Executive Assistant to the Vice President of Client Services> Created processes to increase efficiency of financial transactions in food consumption> Presented logistics documentation process to management(World Airways is a global provider of passengers and cargo air transportation services to the U.S. Military Services, major international airlines and freight forwarders, international leisure tours and cruise ship companies)

Anuva Innovations
Jun 2013 - Feb 2015> Focus in mechanical design for manufacturing> Documentation specialist > Company volunteer coordinator > Embedded software programmer on medical device prototypes> SolidWorks to draw and model individual prototype parts> Composed documentation for FDA approval of medical devices
Biomedical Engineer
May 2014 - Feb 2015Engineering Intern
Jun 2013 - May 2014

The University of North Carolina at Chapel Hill
Dec 2013 - May 2014Teaching Assistant> Provided additional support for upper level Systems and Signals Processing lecture> Organized and led Matlab-based programming lab> Responsible for grading and class material maintenance

Hanover Research
Feb 2015 - Feb 2016Senior Associate, Strategy and New Product Development
Aug 2015 - Feb 2016Business Development Associate
Feb 2015 - Aug 2015

FDA
Feb 2016 - Apr 2019Biomedical EngineerJoints and Fracture Fixation Branch IIDivision of Orthopedic DevicesOffice of Device EvaluationCDRH

MCRA, LLC
Apr 2019 - nowDirector
Licenses & Certifications
- View certificate

RAC-US
Regulatory Affairs Certification ProgramDec 2018
Honors & Awards
- Awarded to Veronica Fleck DownenHonorary Member National Honor Society of Leadership and Success
- Awarded to Veronica Fleck DownenPeople Helping People Scholar State Employees Credit Union
Volunteer Experience
Instructor/Coach
Issued by Superior Gymnastics on Sept 2014
Associated with Veronica Fleck DownenRecognition Chair
Issued by Biomedical Engineering Club on Mar 2013
Associated with Veronica Fleck DownenVolunteer
Issued by Animal Protection Society of Durham on Jun 2012
Associated with Veronica Fleck DownenGymnastics Instructor/Representative
Issued by The Tumble Gym on Jun 2011
Associated with Veronica Fleck DownenVolunteer/Intern
Issued by Scott Safety on May 2013
Associated with Veronica Fleck Downen
Languages
- spSpanish
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