Kesley Gallagher BA, MS

Kesley Gallagher has over 18 years progressive Regulatory Affairs and Quality Assurance in the medical device and pharmaceutical industries. She has 510(k) cleared and CE Marked products in contact lens solutions and femtosecond lasers and indications for use expansion with the femtosecond laser. Her work includes extensive experience with design controls and software in new product development as well as change control for products in the US and internationally. She currently works in Regulatory Affairs at Amgen in new device development for combination products to support the development, submission, and approval of multiple novel drug delivery devices with marketed and new molecular entities.

Kesley holds a BA from Bowdoin College in Biology/Chemistry and an MS in Regulatory Sciences from University of Southern California School of Pharmacy.