Senior Director – Regulatory Intelligence, FDA Engagement

Medline Industries, LP

. Develop and execute the global regulatory intelligence strategy .

Posted 11/4/2026full-timeRemote • United StatesSenior💰 $203,000 - $305,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Regulatory Affairs and Quality leadership, with a strong focus on developing and executing regulatory intelligence strategies, managing compliance commitments, and leading cross-functional teams through regulatory negotiations and remediation activities.

Highest-signal resume keywords

Regulatory Intelligence Strategy DevelopmentFDA Enforcement Actions ResponseCross-Functional Team LeadershipGlobal Health Authority InteractionRegulatory Risk Assessment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsQuality LeadershipRegulatory Response AuthoringRisk-Based ComplianceRegulatory Change AssessmentStrategic ForecastingRemediation PlanningRegulatory NegotiationImpact AssessmentDashboard Preparation

Soft Skills

LeadershipCollaborationCommunicationStrategic ThinkingProblem Solving

Industry Keywords

Medical DevicesPharmaceuticalsBiologicsCombination ProductsFDAEuropean CommissionHealth CanadaPMDATGAHCT/P Products

About the role

Key responsibilities & impact

Develop and execute the global regulatory intelligence strategy
Direct enterprise-wide impact assessments for significant regulatory changes
Prioritize regulatory changes based on business, compliance, product, and patient risk
Coordinate cross-functional action plans and executive escalations
Establish governance, policies, procedures, and metrics for regulatory intelligence activities
Build a centralized regulatory intelligence function supporting all product categories and global markets
Develop long-range regulatory risk assessments and strategic forecasting capabilities
Identify emerging regulatory trends and advise leadership on potential business impacts
Prepare dashboards covering regulatory changes, compliance risks, industry trends, emerging enforcement themes, and strategic opportunities
Serve as an enterprise expert in developing, reviewing, and approving regulatory response strategies
Lead preparation of responses to FDA Form 483 observations, FDA Warning Letters, Untitled Letters, regulatory meeting commitments, requests for information, inspection follow-up correspondence, and compliance and enforcement actions
Ensure regulatory responses are scientifically sound, strategically aligned, risk-based, defensible to regulators, and supported by appropriate remediation plans
Guide cross-functional teams through regulatory negotiations, commitments, and remediation activities

Requirements

What you’ll need

Bachelor’s degree in Regulatory Affairs, biology, microbiology, biomedical engineering, pharmaceutical science, chemistry, life sciences, or related field
10+ years of progressive Regulatory Affairs and/or Quality leadership experience
8+ years interacting directly with global health authorities
Significant experience in highly regulated healthcare industries, including Medical Devices, Pharmaceuticals/OTCs, Combination Products, Biologics, Human Tissue/HCT/P products, and Nutritional Supplements
Direct authorship of multiple FDA-483/Warning Letters and other responses to regulatory agencies
Extensive experience authoring, reviewing, and leading regulatory responses to FDA enforcement actions
Direct authorship of multiple FDA Warning Letter responses
Direct authorship of numerous FDA Form 483 responses
Development of remediation commitments and implementation plans
Management of ongoing correspondence with FDA regarding compliance commitments
Leadership of cross-functional teams supporting inspection response and remediation activities
Experience negotiating regulatory commitments and demonstrating effectiveness of corrective actions
Preferred: 15+ years of progressive experience in Quality and/or Regulatory leadership roles
Preferred: Experience establishing or leading a Regulatory Intelligence function
Preferred: Experience supporting enterprise-wide quality transformation or remediation programs
Preferred: Experience operating across FDA, European Commission / EMA, Health Canada, PMDA, TGA, and MFDS jurisdictions
Preferred: Experience leading enterprise-level FDA remediation programs involving multiple facilities, product lines, and compliance workstreams

Benefits

Comp & perks

Competitive total rewards package
Continuing education & training
Health insurance
Life and disability insurance
401(k) contributions
Paid time off
Employee Assistance Program
Employee Resource Groups
Employee Service Corp
Bonus and/or incentive eligibility
Career growth opportunities