Leonel Vanegas MBA, MS

Leonel has over 21 years of experience with Class I-III medical devices, drugs, and combination products from concept to launch in a GMP and QSR environment. He has an MS in Regulatory Affairs from San Diego State University and a B.S. in Chemistry from Florida International University. He has four ASQ certifications (CSSBB, CQE, CQM-OE, CBA) and is a Six Sigma Black Belt. He is experienced in regulatory filings, risk management, design controls, and FDA-483 or Warning Letter remediation.

He has worked in Fortune 100 companies developing life-saving/sustaining products for the treatment of cardiovascular, oncology, diabetes, women’s health, and infectious diseases. He has built and developed teams to support a regulatory submission for US and global market approvals. Leonel has experience with Pharma/Device QMS integration per FDA 21CFR part 4, 210/211, and 820 and has vast experience with EU MDRs and international standards (ISO13485 & ISO14971). He currently has quality oversight for combination products at Merck.