Amanda is Senior Director, Global Regulatory Affairs - Medical Devices and Combination Products at Pfizer. She has 23 years industry experience working at Pfizer R&D UK, Ltd. Amanda’s focus for the majority of those has been providing strategic support to global development programs and lifecycle management for a broad range of medical device, in-vitro diagnostic and drug-device combination products. Amanda is an active participant in a number of Industry Associations, including EFPIA where she is a co-chair on the ERAO and MQEG working groups relating to medical devices and drug-device products. Amanda is also a contributor to ICH working groups and several ISO standard technical committees, which included the ISO 20069 standard for Assessment of Changes to Drug Delivery Systems issued in 2019 and more recently the revision to ISO 11608 series. Her career started as an Analytical Chemist after obtaining a degree in Chemistry, before moving into a regulatory role in 2005.