Leo Toay

Leo Toay has a diverse and extensive work experience in the medical device industry. Leo is currently serving as the Vice President of Regulatory Affairs at ShiraTronics, Inc since April 2021. Prior to this, from March 2018 to April 2021, they worked as the Sr. Director of Regulatory Affairs and Quality Assurance at Mainstay Medical. Before that, Leo worked as a Quality, Design Assurance, and Regulatory Consultant at QRE Inc from December 2015 to April 2021. Leo provided various services related to CE marking, IDE and PMA submissions, and technical file creation for multiple clients.

Leo also has experience as a Quality, Design Assurance, and Regulatory Consultant at their own company, Toaytech LLC, from June 2010 to December 2015. During this time, they provided a range of consulting services in the medical device industry, including risk management, FDA compliance, quality systems support, and supplier management. Leo also worked with specific clients, such as CCC-Uruguay and Oscor, Inc.

Leo's earlier roles include serving as the Sr. Director of Quality and Regulatory at Respicardia, Inc. from March 2009 to August 2012. Prior to that, they worked as the Quality Director at Transoma Medical from March 2006 to March 2009, and as the Reliability Manager at Pulmonetic Systems from March 2003 to March 2006. Leo's career in the medical device industry started in 1993 at Medtronic, where they held the position of Sr. Reliability Manager for an extended period of time.

Leo Toay completed their Bachelor of Science (B.S.) degree in Electrical and Electronics Engineering and Chemistry at North Dakota State University from 1982 to 1987. Later, they pursued a Master of Business Administration (M.B.A.) degree at the University of Minnesota - Carlson School of Management from 1989 to 1992.