Senior Director of Regulatory Affairs

Cleveland Diagnostics•Cleveland, OH

1d•$125,000 - $225,000•Hybrid

About The Position

The Senior Director of Regulatory Affairs provides strategic and operational leadership for regulatory affairs activities supporting Cleveland Diagnostics’ in vitro diagnostic (IVD) and laboratory developed test (LDT) portfolio, including products for early cancer detection and other clinical indications. The role leads global regulatory strategies across the product lifecycle, including pre-market submissions, post-market obligations, agency interactions, and compliance with applicable U.S. and international requirements. This position serves as the company’s senior regulatory subject matter expert for FDA-regulated IVD products and applicable international pathways. It leads submissions such as PMAs, PMA supplements, amendments, annual reports, and 510(k)s, along with IVDR Technical Documentation and other jurisdictional documentation where applicable. The role combines executive-level strategic guidance with hands-on oversight of submission execution, regulatory documentation, and compliance. The Senior Director provides regulatory direction to executive leadership and cross-functional teams, assesses regulatory pathways and risks, and guides product development, clinical and analytical validation, change management, launch readiness, and post-market compliance. The role also leads regulatory personnel and external resources as needed, promotes regulatory excellence and documentation discipline, and participates in the Senior Leadership Team. The position may be hybrid, with Cleveland-area candidates preferred, and may require occasional business travel.

Requirements

At least 10 years of progressive regulatory affairs experience in the medical device, diagnostics, or IVD industry.
Significant experience with FDA-regulated IVD products.
Demonstrated leadership experience with FDA submissions, including PMAs, PMA supplements, amendments, annual reports, 510(k)s, pre-submissions, and responses to FDA questions.
Experience leading regulatory strategy for product development, clinical validation, analytical validation, design changes, manufacturing changes, and post-market compliance.
Deep working knowledge of FDA medical device and IVD regulations, PMA and 510(k) requirements, 21 CFR 820/QMSR, ISO 13485, CLIA, IVDR, and relevant FDA guidance.
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 programs, competing priorities, 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 and Excel, including complex document formatting, templates, styles, tracked changes, tables of contents, cross-references, and large technical documents.
Ability to work effectively in a growing, fast-paced organization and participate hands-on as needed.
Ability to climb stairs if elevator access is unavailable; sit and/or stand and operate a computer and other technology-related equipment throughout the workday.
Maintain confidentiality of proprietary, clinical, regulatory, and business-sensitive information.

Nice To Haves

Experience with blood-based diagnostics, oncology diagnostics, laboratory-developed tests, companion diagnostics, and early cancer detection products.
Experience with IVDR Technical Documentation, Notified Body interactions, and international regulatory submissions.
Experience managing regulatory personnel, consultants, vendors, or cross-functional submission teams.
Experience supporting FDA inspections, audits, quality system activities, complaint evaluations, vigilance reporting, or post-market surveillance.
Cleveland-area candidates are preferred.

Responsibilities

Develop and execute regulatory strategies for new and existing IVD and LDT products throughout the product lifecycle.
Serve as the senior regulatory subject matter expert for U.S. FDA and applicable international requirements related to IVD and LDT products.
Provide regulatory guidance to executive leadership and product development, 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 activities.
Translate regulatory requirements into development, clinical, medical affairs, quality, manufacturing, and submission plans; anticipate regulatory risks and develop mitigation strategies.
Lead interactions, when appropriate, with outside legal, regulatory, and statistical consultants.
Plan, prepare, review, submit, and maintain regulatory submissions and related documentation, including PMAs, PMA supplements, amendments, annual reports, 510(k)s, FDA correspondence, and international 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 submissions are accurate, complete, scientifically sound, strategically positioned, and submitted on time and in accordance with applicable requirements.
Review technical, clinical, analytical, manufacturing, labeling, and quality documentation for regulatory consistency and compliance.
Assess product development, design, manufacturing, process, labeling, clinical, and analytical changes; determine applicable reporting or submission requirements.
Partner with Quality Assurance, Manufacturing, IVD Test Development, Clinical Operations, and other functions to ensure changes are assessed, documented, and implemented compliantly.
Oversee maintenance of product approvals, listings, registrations, supplements, amendments, post-approval reports, and related domestic and international records.
Lead post-market regulatory activities, including surveillance, vigilance reporting, adverse event assessment, field action support, annual reporting, and record maintenance.
Track and fulfill post-market obligations under FDA, IVDR, and other applicable requirements; support complaints, CAPAs, nonconformances, audits, inspections, and regulatory reporting decisions.
Monitor evolving requirements, guidance, standards, and enforcement trends and communicate relevant implications internally.
Lead cross-functional regulatory planning and execution, including with external consultants.
Provide regulatory leadership for product development teams, clinical study teams, design control activities, and launch readiness planning.
Build, manage, and mentor regulatory personnel, consultants, and vendors as needed; establish roles, timelines, deliverables, and accountability.
Promote regulatory excellence, scientific rigor, documentation discipline, and compliance.
Develop, implement, and maintain regulatory policies, procedures, templates, intelligence processes, and submission standards.
Ensure regulatory documentation systems support accuracy, traceability, version control, and inspection readiness; oversee document management for technical files and submission packages.
Improve regulatory processes, tools, and templates to support quality, efficiency, and compliance.
Represent Regulatory Affairs in leadership meetings, project governance, audits, inspections, and external regulatory engagements.
Provide regulatory input for business development, partnership, investor, or commercial activities as requested.
Participate as an integral member of the Cleveland Diagnostics Senior Leadership Team and perform other duties as assigned.

Benefits

100% employer-paid medical coverage for single coverage effective on date of hire; 50% employer-paid medical coverage for spouse/dependent coverage.
100% employer-paid dental and vision coverage for the entire family.
No-cost employee coverage for Group Term Life, Short-Term Disability, and Long-Term Disability.
4% employer retirement contribution match.
Incentive Performance Plan, Stock Option Program, and Commission program.
Generous PTO and holiday program.
Flexible work schedule.
Employee referral program.
Newly built-out office space at an accessible office location.
Free coffee, snacks, and other goodies throughout the day.