Medtech consulting and clinical research firm MCRA said it has hired Michael C. John, the former chief of FDA’s interventional cardiology devices branch, as its new vice president of cardiovascular regulatory affairs.
At FDA, John supervised and led a multi-disciplinary team of scientists and healthcare professionals on the regulation of interventional cardiovascular Class II and Class III medical devices. He reviewed and edited scientific memoranda from staff relating to all regulatory decisions on premarket, investigational and 510(k) submissions for coronary interventional products. He also discussed the regulation of products in the rapidly evolving interventional cardiovascular device arena with industry representatives, advisory panel members, scientific experts and cardiovascular thought leaders.
Prior to becoming branch chief, John was an animal testing reviewer and lead reviewer in FDA’s cardiovascular devices division. Before joining FDA, John conducted cardiovascular research at Massachusetts General Hospital in Boston, where he specialized in cardiovascular pathology and histology, and performed stent implantation procedures in animal models.
“Michael is a recognized expert with an extensive background in cardiovascular device regulation and physiology, and his appointment reflects MCRA’s strong commitment to providing first-rate regulatory services to the cardiovascular community,” said MCRA general manager David Lown in a prepared staetement. “We are honored Michael has joined MCRA. He will make a tremendous impact.”
Founded in 2004, MCRA is based in Washington, D.C.