Kirsten Paulson, RAC, is the Senior Director, Global Regulatory CMC-Medical Devices at Pfizer Inc., with the lead for Combination Products, diagnostics and software medical devices. She was previously the Senior Officer, Medical Device Initiative of The Pew Charitable Trusts and Head of the PPD Medical Device and Diagnostics Consulting group. She began her career as an FDA medical device reviewer. Kirsten has a BS in Biomedical Engineering from Boston University and an MS in Bioengineering from Penn State.