Michelle Wells, RAC

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.

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