Global Regulatory Intelligence & FDA Strategy Lead

Medline; United States; Remote; USD 203,000 - 305,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline is seeking a Senior Director Regulatory Intelligence, FDA Engagement, to establish and lead a world-class regulatory intelligence capability across Medical Devices, Pharmaceuticals, Cosmetics, and related products. You will partner with Regulatory Affairs, Quality, R&D, and Executive Leadership to translate regulatory changes into timely, risk-based business decisions.

Ideal candidates have extensive experience with FDA enforcement actions and a proven track record in remediation

Qualifications

• 10+ years of progressive Regulatory Affairs and/or Quality leadership experience.
• 8+ years interacting directly with global health authorities.
• Direct authorship of multiple FDA-483/Warning Letters and other responses to regulatory agencies.
• Experience negotiating regulatory commitments and remediation actions.

Responsibilities

• Develop and execute the global regulatory intelligence strategy.
• Lead preparation of responses to FDA observations and enforcement actions.
• Coordinate cross-functional action plans and executive escalations.
• Establish governance, policies, procedures, and metrics for regulatory intelligence activities.

Skills

Regulatory strategy

FDA engagement

Cross-functional leadership

Regulatory responses

Regulatory enforcement actions

Education

Bachelor’s degree in Regulatory Affairs

Master’s degree in Regulatory Affairs

Job description

Medline is seeking a Senior Director Regulatory Intelligence, FDA Engagement, to establish and lead a world-class regulatory intelligence capability across Medical Devices, Pharmaceuticals, Cosmetics, and related products. You will partner with Regulatory Affairs, Quality, R&D, and Executive Leadership to translate regulatory changes into timely, risk-based business decisions.

Ideal candidates have extensive experience with FDA enforcement actions and a proven track record in remediation