Senior Director of Regulatory Affairs

Job Title: Senior Director of Regulatory Affairs

Reports to: Chief Medical Officer

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, as well as international regulatory documentation, including IVDR Technical Documentation and other jurisdictional requirements where applicable. This position requires strong strategic judgment, integrity, deep knowledge of IVD and other regulatory pathways, excellent technical writing and review capabilities, and the ability to lead cross‑functional teams through complex regulatory programs.

The role is expected to operate at both a strategic and hands‑on level, providing executive‑level regulatory guidance while ensuring high‑quality execution of submissions, regulatory documentation, and compliance activities.

• Lead the development and execution of regulatory strategies for new and existing IVD and LDT products throughout the product lifecycle.
• Serve as the company’s senior regulatory subject matter expert for U.S. FDA and applicable international regulatory requirements related to IVD and LDT products.
• Provide strategic regulatory guidance to executive leadership, product development teams, clinical operations, medical affairs, quality assurance, manufacturing, legal/compliance, and commercial stakeholders.
• Assess regulatory pathways, submission requirements, approval risks, and post‑market obligations for new products, expanded indications, product modifications, and lifecycle management activities.
• Translate regulatory requirements into actionable development, clinical, medical affairs, quality, manufacturing and submission plans.
• Anticipate regulatory risks and develop mitigation strategies to support timely product development, approval, launch, and post‑market maintenance.
• Lead interactions when appropriate with outside legal, regulatory, and statistical consultants.

• Lead the planning, preparation, review, submission, and maintenance of regulatory submissions and related documentation, including PMAs, PMA supplements, amendments, annual reports, 510(k) s, FDA correspondence, and international regulatory dossiers.
• Oversee preparation and maintenance of IVDR Technical Documentation and other international regulatory documentation, as applicable.
• Lead or support interactions with FDA, Notified Bodies, and other regulatory authorities, including meeting requests, pre‑submission activities, responses to questions, deficiency responses, and post‑approval communications.
• Ensure regulatory submissions are accurate, complete, scientifically sound, strategically positioned, and submitted in accordance with applicable timelines and requirements.
• Provide senior‑level review of technical, clinical, analytical, manufacturing, labeling, and quality documentation for regulatory consistency and compliance.

• Lead regulatory assessment of product development activities, design changes, manufacturing changes, process changes, labeling changes, and clinical or analytical updates.
• Determine appropriate regulatory reporting or submission requirements for product and process changes.
• Partner with Quality Assurance, Manufacturing, IVD Test Development, Clinical Operations, and other functions to ensure changes are properly assessed, documented, and implemented…