[Hiring] Senior Director Regulatory Intelligence & FDA Engagement @Medline Industries, LP

Role Description

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.

Qualifications

• 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 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.

Requirements

• 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.

Benefits

• Competitive total rewards package.
• Continuing education & training.
• Tremendous potential with a growing worldwide organization.
• Health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.