Senior Director of Regulatory Affairs

Role summary

Senior Director of Regulatory Affairs is a full-time role at Cleveland Diagnostics in Cleveland, Ohio, United States (hybrid). Posted 2026-10-22. Salary: USD 125,000–225,000 per year. Experience level: 10+.

Job title

Senior Director of Regulatory Affairs

Company

Cleveland Diagnostics

Location

Cleveland, Ohio, United States

Work arrangement

hybrid

Employment type

full-time

Category

Healthcare Support

Salary

USD 125,000–225,000 per year

Experience level

10+

Date posted

2026-10-22

Job description

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, 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.

Essential Duties & Responsibilities

Regulatory Strategy and Leadership

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.

Regulatory Submissions and Agency Interactions

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.

Product Lifecycle and Change Management

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 in compliance with regulatory requirements.

Oversee maintenance of product approvals, listings, registrations, supplements, amendments, post-approval reports, and related regulatory records on a domestic and international basis.

Post-Market Regulatory Compliance

Provide leadership for post-market regulatory activities, including post-market surveillance, vigilance reporting, adverse event assessment, field action support, annual reporting, and regulatory record maintenance.

Ensure post-market regulatory obligations are identified, tracked, and fulfilled in accordance with FDA, IVDR, and other applicable requirements.

Support quality system activities related to complaints, CAPAs, nonconformances, audits, inspections, and regulatory reporting decisions.

Monitor evolving regulatory requirements, guidance documents, standards, and enforcement trends and communicate relevant implications to internal stakeholders.

Cross-Functional Collaboration and Organizational Leadership

Lead cross-functional regulatory planning and execution with Clinical Operations, Legal and Compliance, IVD Test Development, Quality, Manufacturing, Commercial, Medical Affairs, and external consultants.

Provide regulatory leadership for product development teams, clinical study teams, design control activities, and launch readiness planning.

Build, manage, and mentor regulatory affairs personnel, consultants, and vendors as needed.

Establish clear regulatory roles, timelines, deliverables, and accountability across internal and external teams.

Promote a culture of regulatory excellence, scientific rigor, documentation discipline, and compliance.

Regulatory Systems, Policies, and Documen