My Experience

30 Years

I've spent more than 30 years in the medical device industry in various regulatory affairs roles with the leading medical device manufacturers.  My last position was Vice President, Corporate Regulatory Affairs, Medtronic, Inc.

Since 2017, as an independent consultant, I’ve provided the regulatory leadership for all FDA device pathways, including EUA’s during the COVID-19 pandemic. I’ve provided hands on leadership in digital health. I’ve supported FDA advisory panels. Clients have included large multinational corporations; a large pharmaceutical corporation; device manufacturers based in Israel, Japan, and Korea; and entrepreneurial start-ups in the United States.

Partnership

I approach FDA as a partner rather than an opponent.  I know most FDA CDRH counterparts to be fact-based professionals dedicated to protecting and promoting public health through access to safe and effective medical devices.

Panel Experience

Extensive FDA advisory committee experience, including service as industry representative of the circulatory devices advisory panel.