$125,000 - $225,000 yearly
Cleveland Diagnostics Inc.
Cleveland, OH
Senior Director of Regulatory Affairs Job Title: Senior Director of Regulatory Affairs Reports to: Chief Medical Officer Job Overview The Senior Director of Regulatory Affairs will provide strategic and operational leadership for regulatory affairs activities supporting Cleveland Diagnostics' in vitro diagnostic (IVD) and laboratory developed test (LDT) product portfolio, including tests/assays intended for early cancer detection and other clinical indications. This role will lead the development, execution, and maintenance of global regulatory strategies across the full product lifecycle, including pre-market submissions, post-market obligations, regulatory agency interactions, and ongoing compliance with applicable U.S. and international regulatory requirements. The Senior Director will serve as a regulatory leader for FDA-regulated IVD products, including PMA, PMA supplement, 510(k), amendment, annual report, and post-approval submission activities,...