Yesmil Pena

Quality Assurance and Regulatory Affairs

Yesmil has served in quality systems management and regulatory affairs positions in the therapeutics, in-vitro diagnostics, and active low to high-risk medical device areas for the past 20 years. She has led successful projects from quality systems establishment, integration, auditing, and maintenance, to achieving regulatory approvals in the United States, Canada, Europe, and other jurisdictions. Previously, Yesmil’s roles included Quality Systems Lead at Perimeter Medical (2018), Manager of Quality Assurance and Regulatory Affairs at Meditech International (2016-2018). Manager and Director roles Spectral Medical, Inc., from 2003-2006 and 2008-2015). Also, Yesmil led the Quality Systems integration at Nanogen, Inc. (2006-2008), a former US-based company – acquirer of Spectral’s Cardiac line. Yesmil has earned regulatory affairs and quality certifications along her career, her B.A. Sc in Industrial Engineering from Universidad Dominicana O&M in the Dominican Republic, a Master Certificate in Enterprise Risk Management from York University and an EMBA from the University of Fredericton. In 2021, Yesmil founded St. Philip Neri’s Table, a non-profit organization with more than 50 volunteers serving diverse population and intended to offer short to long term solutions for the current food insecurity crisis.