BIO
Sara
Coon
Director, Regulatory Affairs
Halozyme, Inc
Sara Coon leads Combination Product Regulatory strategies and submissions at Halozyme, Inc., bringing over 30 years of experience in the medical device and pharmaceutical industries. As a Regulatory Affairs Director, she has supported approvals of PMAs, IDEs, NDAs, MAFs, and 510(k)s. Her EU expertise includes implementing ISO 13485 compliant quality systems and preparing GSPR (formerly ER) checklists and Technical Dossiers for devices and combination products. With broad knowledge in Quality Systems and Regulatory Affairs, Sara is dedicated to ensuring the products she develops are safe and effective for the patients who depend on them.
