Experience

OrganOx

• United Kingdom
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Vice President of Regulatory Affairs, North America

  • Feb 2021 - Present



ProNova Solutions

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director of Quality Assurance and Regulatory Affairs

  • 2018 - Feb 2021



IKARIA, Inc. - now a part of Mallinckrodt Pharmaceuticals.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Associate Director, Device Regulatory Affairs

  • 2012 - 2016



Accuray Incorporated / TomoTherapy Incorporated

• Director of Regulatory Affairs

  • 2004 - 2012

  Managed 17-person RA department responsible for all pre-market certification, post-market surveillance and product risk management activities for all products developed and manufactured at the Madison facility and the corporate headquarters in Sunnyvale, CA Managed 17-person RA department responsible for all pre-market certification, post-market surveillance and product risk management activities for all products developed and manufactured at the Madison facility and the corporate headquarters in Sunnyvale, CA