Sr Dir Regulatory Intelligence & FDA Engagement

Job Summary

The Senior Director Regulatory Intelligence, FDA Engagement is responsible for establishing, leading, and continuously evolving a world-class regulatory intelligence capability that proactively identifies, assesses, communicates, and drives implementation of global regulatory requirements and emerging regulatory trends across the organization's portfolio. This leader serves as the enterprise authority for regulatory intelligence, providing strategic insight into evolving regulations, guidance documents, standards, enforcement actions, inspection trends, and policy developments that impact Medical Devices,
Pharmaceuticals, Cosmetics, Human Tissue/HCT/P products, and Combination Products. The position partners closely with Regulatory Affairs, Quality, R&D, Medical Affairs, Supply Chain, Manufacturing, Legal, and Executive Leadership to ensure regulatory changes are translated into timely, risk-based business decisions and compliant implementation plans. Given the organization's significant interaction with global health authorities, this role requires deep experience managing regulatory enforcement activities and developing successful responses to FDA observations, Warning Letters, and other regulatory actions.

Job Description

MAJOR RESPONSIBILITIES:

Develop and execute the global regulatory intelligence strategy. Including:

• Direct enterprise-wide impact assessments for significant regulatory changes.
• Ensure appropriate prioritization 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 that drive implementation of regulatory requirements.
• 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 summarizing:

• Regulatory changes
• Compliance risks Industry trends
• Emerging enforcement themes
• 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
• Compliance and enforcement actions

• Ensure responses are:

• Scientifically sound
• Strategically aligned
• Risk-based
• Defensible to regulators
• Supported by appropriate remediation plans
• Guide cross-functional teams through regulatory negotiations, commitments, and remediation activities.

MINIMUM JOB REQUIREMENTS:

Education:

• Bachelor’s degree in Regulatory Affairs, biology, microbiology, biomedical engineering, pharmaceutical science, chemistry, life sciences, or related field.

Certification / Licensure:

• None

Work Experience:

• 10+ years of progressive Regulatory Affairs and/or Quality leadership experience
• 8+ years interacting directly with global health authorities
• Significant experience within highly regulated healthcare industries including:
• Medical Devices
• Pharmaceuticals/OTCs
• Combination Products
• Biologics
• Human Tissue/HCT/P products
• Nutritional Supplements
• Direct authorship of multiple FDA-483/Warning Letters and other responses to regulatory agencies

Knowledge / Skills / Abilities:

• Extensive demonstrated 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 JOB REQUIREMENTS:

Education:

• Master’s degree in Regulatory Affairs, Project Management, or similar field, but not required.

Certification / Licensure:

• None

Work Experience:

• 15+ Years experience with progressive experience in Quality and/or Regulatory leadership roles
• Experience establishing or leading a Regulatory Intelligence function.
• Experience supporting enterprise-wide quality transformation or remediation programs.
• Experience operating across multiple major regulatory jurisdictions including:
• FDA
• European Commission / EMA
• Health Canada
• PMDA
• TGA
• MFDS
• Experience leading enterprise-level FDA remediation programs involving multiple facilities, product lines, and compliance workstreams.

Knowledge / Skills / Abilities:

• None

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$203,000.00 - $305,000.00 Annual

…