Senior Regulatory Lead, IVD & FDA Submissions

Cleveland Diagnostics, Inc. is seeking a Senior Director of Regulatory Affairs to lead global regulatory strategy across the full product lifecycle for FDA-regulated IVDs and LDTs.

The role requires executive-level guidance, cross-functional collaboration, and hands-on submission leadership. The successful candidate will oversee PMAs, 510(k)s, and international documentation, ensuring compliant, timely filings and ongoing post-market oversight.