BIO
Fatemeh
Razjouyan
Director of Regulatory Policy, International and Harmonization
Medtronic
As part of Medtronic’s global regulatory policy team in Washington, D.C., Fatemeh Razjouyan is actively shaping the global regulatory landscape to promote harmonization. She represents Medtronic in industry working groups and coalitions to advance its goal of providing patients with safe and innovative therapies. Razjouyan was previously the head of U.S. regulatory policy in B.D. Prior to that, she held various roles in the Center for Devices and Radiologic Health (CDRH) at the U.S. Food and Drug Administration (FDA). From 2013 to 2018, she led the 510(k) review program in the Office of In Vitro Diagnostics and Radiological Health (OIR) in CDRH, where she trained review staff, drafted guidance documents and work instructions, and assisted in the implementation of the Medical Device User Fee Amendments (MDUFA) and regulatory policy for the 510(k) program.
