SME Profile

27 years of experience in Medical Devices and In Vitro Diagnostics in a variety of functions for industry (Research, Manufacturing, Engineering and Regulatory Affairs), a Notified Body, and a consulting firm.

Sr. Principal Advisor and VP of Regulatory Affairs & Quality Systems at a consulting firm until 2009 providing guidance on all aspects of quality system implementation and compliance, as well as, regulatory strategies, submissions, and negotiations with Notified Bodies and the FDA.

Regional Operations Manager for the Notified Body TÜV Product Service Inc until 2000 providing Notified Body Auditor services for CE certification to the MDD, AIMD, and IVD directives.  Also responsible for the FDA 510(k) Third Party Reviewer program.

Held various management and individual contributor positions at 3 major IVD companies until 1996.

Speaker and instructor in areas of Regulatory Affairs and Quality Systems.