Meredith May, MS, RAC

Empirical-Meredith-May

Meredith May, MS RAC

VP Empirical Consulting

PROFESSIONAL CREDENTIALS

Biomedical engineer educated and experienced in business practices with extensive experience in all aspects of medical devices. Expert in creating medical device quality systems, including Design Controls, Process Validation, Equipment Qualification, Failure Modes & Effects Analysis, Regulatory Affairs, and Product Realization

Regulatory Affairs Certified (RAC) by Regulatory Affairs Professionals Society (RAPS). Completed RAPS Medical Device Certificate. Written 30+ 510(k) applications and international filings.

Certified Quality Auditor (CQA) by American Society for Quality (ASQ). Certification number 65034, expires 31Dec18. Completed 1-2 internal and/or supplier audits per quarter in 2015.

TRAINING + INDUSTRY PAPERS

  • 510(k) Training given in Seoul, South Korea to top 100 medical device companies (twice in 2015)
  • Authored chapter about Risk Assessment for Fundamentals of US Regulatory Affairs, Ninth Edition (2015)
  • Board of Directors, The Perry Initiative Non-Profit Orthopedic Organization (2012-2014)
  • Industry Advisory Council Member for Florida Banner Center of the Life Sciences (2009-2011)
  • Curriculum Developer and Professional Trainer at the Banner Center for the Life Sciences (2010-2012)
  • Presentations about medical device testing, quality, and regulatory given at professional conferences, including OrthoTec and OrthoTec Europe (2012-Present)
  • Satellite Presentations about device testing given at NASS and AAOS (2012-Present)

CAREER LEADERSHIP

  • Employee of the Quarter, Empirical Testing Corp
  • Thomas S. Johnson Entrepreneurial Scholar Award, University of Florida
  • Beta Gamma Sigma International Honor Society, University of Florida
  • Presidential Delta Quality Award, Biomet 3i
  • Fish Philosophy Award at the Quality Summit, Biomet 3i
  • Quality Improvement Project Team Leader, Biomet 3i
  • Founders’ Scholarship, Tulane University
  • Congress-Bundestag Exchange Scholarship to study in Germany (Youth for Understanding)
  • Advanced Academic Diploma with Honors, Central High School, Tuscaloosa, Alabama

EDUCATION

shieldword_2color_webTulane University – New Orleans, Louisiana (1993 – 1997)

Bachelor of Science in Biomedical Engineering

 

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University of Florida – Gainesville, Florida (2008 – 2009)

Master of Science in Entrepreneurship (Warrington School of Business)

 

RAPSRegulatory Affairs Professionals Society (RAPS)
Online (2012 – 2013)

RAC Certification Test and Medical Device Certificate