Combination Product Expert Carolyn Dorgan Has Joined Suttons Creek, Inc. As Principal Systems Engineer - Regulatory Affairs

Carolyn Dorgan is bringing her 10+ years of experience in the Medical Device and Combination Product industries, including 6 years leading the FDA’s Infusion Devices team, to Suttons Creek. Known in the international regulatory community from her active speaking engagement schedule, Carolyn has literally “set the standard” by participating in over a dozen international standards ranging from infusion devices to needle-based injection systems, on-body delivery systems, and infant incubators. Her knowledge of international Combination Product standards and, more critically, their interpretation and application to various drug delivery devices will play a crucial role in SCI’s regulatory services team, led by Rob Schulz, VP of Regulatory Affairs & Technical Consulting.