About this opportunity
Cleveland Diagnostics Inc. lists this Senior Regulatory Lead, IVD & FDA Submissions opportunity in cleveland, Ohio. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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.
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Worksite address
cleveland, OH, 44101, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.