Senior Director of Regulatory Affairs

Cleveland Diagnostics Inc.

Cleveland, OH

$125,000–$225,000 Per Year

Today

Job Description

Senior Director of Regulatory Affairs

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 Documentation

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.

Other Duties

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.

Other Requirements

This may be a hybrid position however Cleveland area candidates are preferred
Occasional travel may be required for regulatory meetings, audits, inspections, conferences, partner meetings, or other business needs.
Must be able to maintain confidentiality of proprietary, clinical, regulatory, and business-sensitive information.

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Cleveland Diagnostics, Inc., is developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics.

We pride ourselves in fostering a family-focused, friendly, and flexible organization that places our employee's well-being and happiness as the primary reason for our success. Are you interested in building your career with a team of industry professionals while making a lasting impact to the lives of millions of people? Bring your talents to Cleveland Diagnostics.

Cleveland Diagnostics offers an extremely robust benefits package which includes:

100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
100% Employer-paid Dental & Vision for entire family
No cost for employee coverage for Group Term Life, Short & Long Term Disability
4% retirement contribution Employer match
Incentive Performance Plan & Stock Option Program & Commission program
Generous PTO plan & holiday program
Flexible work schedule & lucrative employee referral program
Salary may vary by work state/geographical region/territory
Easy to get to office location with newly built-out office space
Free coffee, snacks and other goodies all day long

Cleveland Diagnostics is an equal opportunity employer and is committed to providing a workplace free from harassment and discrimination. We celebrate the unique differences of our employees because that is what drives curiosity, innovation, and the success of our business. EEO is the Law. Applicants can learn more about the company's status as an equal opportunity employer by viewing the federal EEO is the Law poster on our careers page. Accommodations are available for applicants with disabilities.

Compensation details: 125000-225000 Yearly Salary

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Numbers & Facts

Location	Cleveland, OH
Salary	$125,000–$225,000 Per Year

Skills

Adverse Eventsunmatched
Assaysunmatched
Budgetingunmatched
Business Developmentunmatched
Cancerunmatched
Change Managementunmatched
Clinical Assessmentunmatched
Clinical Practices/Protocolsunmatched
Clinical Trialunmatched
Clinical Validationunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Conferencesunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Detail Orientedunmatched
Document Managementunmatched
Documentationunmatched
Documentation Formatunmatched
Documentation Standardsunmatched
Drug Developmentunmatched
EEO Regulationsunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
HVACunmatched
Healthcare Qualityunmatched
ISO (International Organization for Standardization)unmatched
Intellectual Property (IP)unmatched
Laboratory Testingunmatched
Leadershipunmatched
Legalunmatched
Manufacturingunmatched
Medical Affairsunmatched
Medical Diagnosisunmatched
Medical Equipmentunmatched
Mentoringunmatched
Microsoft Excelunmatched
Microsoft Wordunmatched
Monitor Regulationsunmatched
Negotiation Skillsunmatched
On Site Supportunmatched
Operational Strategyunmatched
People Managementunmatched
Performance Metricsunmatched
Physical Demandsunmatched
Process Improvementunmatched
Product Developmentunmatched
Product Lifecycleunmatched
Product Lifecycle Managementunmatched
Product Marketingunmatched
Product Supportunmatched
QA Partner Testing Softwareunmatched
Quality Assuranceunmatched
Quality Managementunmatched
Record Keepingunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Reportsunmatched
Regulatory Requirementsunmatched
Regulatory Submissionsunmatched
Risk Managementunmatched
Safety Processunmatched
Scientific Publicationsunmatched
Source Code/Configuration Management (SCM)unmatched
Strategic Planningunmatched
Support Documentationunmatched
Surveillanceunmatched
Systems Administration/Managementunmatched
Team Lead/Managerunmatched
Team Playerunmatched
Technical Editingunmatched
Technical Writingunmatched
Test Plan/Scheduleunmatched
Time Managementunmatched
Traceabilityunmatched
Willing to Travelunmatched
Writing Skillsunmatched

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