Our Team

Julie Schoell joined Biologics Consulting in February 2025 with over 20 years in industry, 15 years specifically in regulatory affairs across medical device, pharmaceutical, and in-vitro diagnostic products. Julie joined Biologics Consulting from her previous role as Associate Director of the human health and animal health diagnostic regulatory team at Zoetis. In this role, she managed local and international compliance for diagnostic devices in both human and animal health. Her notable achievements outside of 510(k) submission support include creating a Quality Plan for In Vitro Diagnostic Devices Regulation 2017/746 (IVDR) implementation, Regulatory Manager of the internal IVD testing laboratory, and leading cross-functional teams to comply with European regulations.

Previously, Julie held various positions at Stryker where she received multiple 510(k) clearances with both patient specific and craniomaxillofacial (CMF) implant devices, was acting U.S. Agent for the CMF division, assessed and determined reporting requirements for customer complaints, and responsible for advertising and promotion compliance. Prior to this, Julie supported FIH and preclinical studies at Pfizer, and managed annual reports and post-market PAS/CBE submissions on radiopharmaceutical and generic APIs at Covidien. In addition to her professional experience, Julie has worked in academia as a Laboratory Manager at Washington University and University of Michigan, as well as an Instructor and IACUC administrator at the Vet Tech Institute at Hickey College.

Julie holds a Master of Science in Orthopedic Regulatory and Clinical Affairs from Grace Seminary College and a Bachelor of Science in Veterinary Technology from Michigan State University. She is a registered veterinary technician in Missouri and holds a Regulatory Affairs Certification (RAC). Julie is an active member of the Regulatory Affairs Professionals Society (RAPS).