Senior Director of Regulatory Affairs

Job Description

Senior Director, Regulatory Affairs

Compensation : $160K to $225K base plus 20% annual bonus target

Schedule : Monday to Friday, 8am to 5pm

Location : Hybrid in Cleveland, OH, with on-site presence one week per month. Relocation assistance may be available if needed.

Overview

Our client is a growing diagnostics company developing blood-based tests for early disease detection. They are seeking a Senior Director of Regulatory Affairs to set regulatory direction and lead execution for a portfolio of in vitro diagnostic and laboratory-developed tests. This leader will own regulatory strategy across the full product lifecycle, from pre-market submissions through post-market compliance, for both U.S. and international markets.

Key Responsibilities

Strategy and Leadership

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• Define and execute regulatory strategies for new and existing diagnostic products
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• Act as the senior regulatory authority for FDA and international requirements
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• Advise executives and cross-functional partners on pathways, risks, timelines, and business impact
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• Anticipate regulatory risks and put mitigation plans in place to protect development and launch timelines
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Submissions and Agency Interaction

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• Lead planning, authoring, review, and filing of FDA submissions, including PMA, PMA supplements, 510(k), amendments, and annual reports
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• Oversee international technical documentation, including IVDR
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• Lead or support interactions with FDA, Notified Bodies, and other authorities, including pre-submission meetings and deficiency responses
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• Provide senior review of technical, clinical, analytical, manufacturing, and labeling documents for accuracy and consistency
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Lifecycle and Change Management

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• Assess regulatory impact of design, manufacturing, process, labeling, and clinical changes
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• Determine reporting and filing requirements for changes
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• Maintain approvals, registrations, and related records globally
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Post-Market Compliance

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• Lead post-market surveillance, vigilance reporting, adverse event assessment, and field action support
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• Support complaints, CAPA, audits, and inspections
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• Track evolving regulations, guidance, and enforcement trends and communicate implications to the business
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Organizational Leadership

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• Build, mentor, and manage regulatory staff, consultants, and vendors
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• Establish roles, timelines, and accountability across internal and external teams
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• Develop regulatory procedures, templates, and document control standards that support inspection readiness
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Requirements

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• 10+ years of progressive regulatory affairs experience in medical device, diagnostics, or IVD
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• Significant experience with FDA-regulated IVD products
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• Demonstrated leadership of FDA submissions, including PMA, PMA supplements, 510(k), pre-submissions, and responses to FDA questions
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• Working knowledge of FDA device and IVD regulations, QMSR, ISO 13485, CLIA, IVDR, and relevant guidance
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• Strong strategic judgment and the ability to advise executive leadership
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• Excellent technical writing and submission review skills
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• Ability to manage multiple complex programs, budgets, and KPIs
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• Advanced Microsoft Word and Excel skills, including large technical documents
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• Ability to maintain confidentiality of sensitive clinical, regulatory, and business information
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This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!