Cinthia Gaona is a results-driven quality and regulatory leader who has shaped the compliance landscape of biotechnology and medical device companies for over 10 years. Holding a B.A. in Chemistry and certifications including PMP, CQA, CSQP, CMQ/OE, CQE, CSSGB, she brings scientific depth and strategic expertise to every initiative. As Director of Quality Assurance/Regulatory Affairs, Enterprise Risk, and Program Management for Vigilant Biosciences®, she has delivered landmark achievements including IVDR certification, successful ISO 13485 audits, and robust quality management system development. Cinthia is dedicated to elevating quality and regulatory standards while supporting innovation in the medical device industry.