Michelle is currently at W.L. Gore & Associates, and is responsible for coordinating approvals for stroke, venous and peripheral products.
Michelle has more than 20 years of experience in drugs and devices, including inhalation drugs and devices (aerosol & powder), vascular grafts, catheter based vascular therapies, suspensions, solutions/injections, creams, ointments, shampoos, nasal sprays, tablets, syrups, diagnostic drugs, wound healing, topical and aesthetic products, and orphan drugs and devices. Michelle’s forte is in early negotiations with FDA, particularly pre-IND and pre-IDE meetings to secure agreement early on in development programs to ensure smooth submissions and subsequent approvals.
In Arizona, she has worked for Schein (Steris/Watson), Zila, The Tech Group, Bard (Impra), Medicis, and Regulatory Compliance Consulting Services. Outside of Arizona, Michelle has worked with Proctor & Gamble, Dey (Mylan), Inale (Nektar), and Pfizer.
Michelle has been a facilitator for the Regulatory Affairs Professional Society and was a member of the faculty for the Regulatory Affairs Certification Workshop. She has been a past member of the Regulatory Affairs review committee for the Regulatory Affairs Certification Study Guide and published, “Regulatory Affairs Certification: Take the Challenge.”[1]
[1] Regulatory Affairs Focus: The Magazine of the Regulatory Affairs Professional Society. Vol. 2, No. 5, p 24-25. May 1997.