Maria Villanueva

Head of Compliance at BioTissue

Speaker

Maria Villanueva leads the Compliance function at BioTissue. BioTissue is the leader in innovative technologies using products derived from human amniotic membrane tissues. In this role she leads the implementation of execution of a compliance program and updates the Audit Committee. Prior to this role, Maria served as VP Compliance Officer at Ra Medical, a medical device and publicly traded company. There she designed and implemented a compliance program in response to a Corporate Integrity Agreement and managed the program during the length of the CIA. She successfully negotiated a release from the obligations of the CIA with DHHS as the company merged.

Prior to these roles Maria has held progressive management roles at Zimmer Biomet, GE Healthcare, Micrus (acquired by Johnson & Johnson), Abbott, and Motorola. She has led compliance with FCPA during DOJ’s monitorship because of violations. Maria has experience setting up compliance operations including developing policies, training, and escalating processes, including the setup of controls around transparency reporting and HCP engagement. She has served as a business partner advising proactively on product launch, country expansion and compliance risk of global business matters, including third party diligence of both vendors and channel partners. She has conducted investigations, monitoring, and auditing the effectiveness of the compliance programs. Maria has also managed compliance in the areas of international trade, and government contracting. She started her career in public accounting working on assurance and forensic accounting practices across multiple industries.

Maria has been a frequent speaker on compliance topics including anti-corruption and the Foreign Corrupt Practices Act (FCPA), Healthcare Transparency Laws and compliance programs. She received a B.S. in Accountancy from DePaul University and an MBA from the University of Miami. Maria is a Certified Fraud Examiner.