Kirsten Paulson

Pfizer, Inc.
Executive Director, Global Regulatory CMC-Medical Devices
Kirsten Paulson, RAC, is Executive 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 group. She began her career as an FDA medical device reviewer. Kirsten has a BS from Boston University and an MS in Bioengineering from Penn State.

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What is the Impact of Article 117 on the Pharma Industry?
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What is the Impact of Article 117 on the Pharma Industry?

Article 117 of the EU Medical Device Regulation (MDR), fully applying May 26, 2021, is significantly impacting BioPharma companies. While integral drug-device combination products (such as pre-filled syringes and pre-filled injectors) are regulated as medicinal products in Europe (EU), certain aspects of the Medical Device Regulation apply to the device component of the product.