Deborah Herrera Email & Phone Number

Debbie Herrera has over 35 years of experience in the medical device, pharmaceutical, and biologics industries with focus in the areas of quality systems, regulatory compliance, and regulatory strategies and submissions. Her experience includes development, implementation and maintenance of quality systems in product development, manufacturing, and commercial operations, regulatory affairs (including FDA inspections, 483 and warning letter responses, competent authority interaction, and global pre-market notifications and registrations), complaint management, regulatory compliance, specifically, adverse events and product recalls, and quality and regulatory training. Debbie has held multiple management roles for Beckman Coulter, Coulter, and Schering-Plough. Debbie has held key quality and regulatory roles with Original Equipment Manufacturing (OEM) and contract manufacturing agreements in the medical device, pharmaceutical, and biologic industries.

Listed skills include Fda, Quality System, Medical Devices, Regulatory Affairs, and 46 others.