Ms. Lenz brings over 12 years hands-on and leadership experience in regulatory affairs and quality assurance. She has worked with development teams of all sizes in the US, Europe and Asia, supporting many active and software controlled device types. She specializes in new product introductions, including regulatory strategy, design controls, risk management, and obtaining market authorizations in the US, Canada, and Europe.
Ms. Lenz is the founder of Pathway Regulatory Consulting and also serves as a Senior Consultant in Regulatory Affairs for Emergo Group. Prior to consulting, she was a Regulatory Affairs Director at GE Healthcare and has held other roles within regulatory affairs and quality assurance with GE Healthcare and Smiths Medical.