Senior Director, Global Regulatory Intelligence & FDA Strategy

Medline Industries, LP; Illinois; Hybrid; USD 203,000 - 305,000; Full time

Benefits offered by this job

Competitive total rewards package

Job summary

Medline Industries, LP is seeking a Senior Director Regulatory Intelligence, FDA Engagement to lead a world-class regulatory intelligence function across Medical Devices, Pharmaceuticals, Cosmetics, and related products. The role partners with Regulatory Affairs, Quality, R&D, and senior leadership to translate regulatory changes into timely, risk-based decisions.

The candidate will steer responses to FDA observations and enforcement actions, guide cross-functional remediation, and ensure

Qualifications

• Bachelor's degree in Regulatory Affairs, biology, microbiology, biomedical engineering, pharmaceutical science, chemistry, life sciences, or related field.
• Significant experience in regulatory leadership within highly regulated healthcare industries, including medical devices and pharmaceuticals.
• Direct authorship of FDA-483/Warning Letters and responses to regulatory actions.

Responsibilities

• Develop and execute the global regulatory intelligence strategy with enterprise-wide impact assessments.
• Build a centralized regulatory intelligence function covering all product categories and global markets.
• Identify emerging regulatory trends and advise leadership on business impacts.

Skills

Regulatory affairs leadership

Quality leadership

FDA enforcement actions

Regulatory communications

Education

Bachelor's degree in Regulatory Affairs or life sciences

Master's degree in Regulatory Affairs (preferred)

Job description

Medline Industries, LP is seeking a Senior Director Regulatory Intelligence, FDA Engagement to lead a world-class regulatory intelligence function across Medical Devices, Pharmaceuticals, Cosmetics, and related products. The role partners with Regulatory Affairs, Quality, R&D, and senior leadership to translate regulatory changes into timely, risk-based decisions.

The candidate will steer responses to FDA observations and enforcement actions, guide cross-functional remediation, and ensure