Senior Director of Regulatory Affairs

Senior Director of Regulatory Affairs

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

• 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 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.
• 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.
• 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.
• Lead the development, implementation, and maintenance of regulatory policies, procedures, templates, regulatory intelligence processes, and submission standards.
• Ensure regulatory documentation systems support accuracy, traceability, version control, and inspection readiness.
• Oversee regulatory document management practices for large, complex technical files and submission packages.
• Support continuous improvement of regulatory processes, tools, and templates to improve quality, efficiency, and compliance.
• Represent Regulatory Affairs in internal leadership meetings, project governance discussions, audits, inspections, and external regulatory engagements.
• Support business development, partnership, investor, or commercial activities by providing regulatory input as requested.
• Participate as an integral member of the Cleveland Diagnostics Senior Leadership Team (SLT)
• Perform other duties as assigned.

Qualifications/Requirements

• Minimum of 10 years of progressive regulatory affairs experience in the medical device, diagnostics, or IVD industry.
• Significant experience with FDA-regulated IVD products required.
• Demonstrated leadership experience with FDA submissions, including PMAs, PMA supplements, amendments, annual reports, 510(k)s, pre-submissions, and responses to FDA questions.
• Experience with blood-based diagnostics, oncology diagnostics, laboratory-developed tests, companion diagnostics, and early cancer detection products preferred.
• Experience with IVDR Technical Documentation, Notified Body interactions, and international regulatory submissions preferred.
• Prior experience leading regulatory strategy for product development, clinical validation, analytical validation, design changes, manufacturing changes, and post-market compliance.
• Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams preferred.
• Experience supporting FDA inspections, audits, quality system activities, complaint evaluations, vigilance reporting, or post-market surveillance preferred.

Knowledge, Skills, and Abilities

• Deep working knowledge of applicable regulatory frameworks, including FDA medical device and IVD regulations, PMA requirements, 510(k) requirements, 21 CFR 820/QMSR, ISO 13485, CLIA, IVDR, and relevant FDA guidance documents.
• Strong strategic judgment and ability to advise executive leadership on regulatory risks, options, timelines, and business implications.
• Excellent technical writing, editing, and regulatory submission review skills.
• Ability to critically assess scientific, clinical, analytical, quality, manufacturing, and technical documentation.
• Strong leadership, communication, negotiation, and cross-functional collaboration skills.
• Ability to manage multiple complex regulatory programs, competing priorities, and time-sensitive deliverables, and regulatory affairs program budgets/KPIs
• Exceptional attention to detail and strong document management, version control, and regulatory records discipline.
• Advanced proficiency with Microsoft Word & Excel, and complex document formatting, including templates, styles, tracked changes, tables of contents, cross-references, and large technical documents.
• Ability to operate effectively in a growing, fast-paced organization with hands-on involvement as needed.

Physical Requirements

• Offices are reachable by elevator; must be able to climb stairs in the event elevator access is unavailable. General office and HVAC noise & fluorescent and/or LED lighting
• Ability to sit and/or stand and operate a computer and other technology-related equipment throughout the workday.
• May occasionally enter laboratory or manufacturing areas and may be exposed to hazardous chemicals, biohazards, or related controlled environments, subject to applicable safety procedures.