[Hiring] Senior Director, Field Corrective Actions @Medline Industries, LP

Role Description

The Senior Director, Field Corrective Actions provides enterprise leadership and strategic direction for the global processes used to evaluate, decide, plan, execute, monitor, and close field corrective actions across diverse business divisions, product portfolios, and regulatory jurisdictions. The Senior Director is accountable for the performance and results of the corporate Field Corrective Action function and associated teams, ensuring actions involving distributed product are risk-based, timely, effective, traceable, and compliant with applicable international regulatory requirements and internal quality system procedures. The role provides leadership through Directors and/or Senior Managers; establishes enterprise governance, decision rights, escalation pathways, performance expectations, and resource priorities; and adapts and executes functional strategies to achieve key patient-safety, regulatory, quality, and business objectives. Decisions made by the role strongly impact the corporate department and Medline business segments. The Senior Director serves as a principal liaison with the U.S. Food and Drug Administration and other regulatory authorities and advises executive, divisional, and functional leaders on significant field action risk, strategy, commitments, and business implications.

Qualifications

• A bachelor’s degree in a scientific, engineering, healthcare, or related technical discipline, or equivalent job-related knowledge.

Requirements

• At least 8 years of experience in medical device, pharmaceutical, biologic, cosmetics, food product, human tissue, or other regulated healthcare or consumer-product quality systems, including at least 5 years of management-level experience.
• Experience overseeing complex recalls, corrections, removals, market withdrawals, stock recoveries, or other field corrective actions involving distributed regulated products.
• Relevant experience in product-specific reportability assessments, regulatory submissions and notifications, health hazard or product risk evaluations, customer and consignee communications, lot or batch traceability, effectiveness checks, reconciliation, disposition, closure, regulatory inspections, and health-authority interaction.

Benefits

• Health insurance
• Life and disability insurance
• 401(k) contributions
• Paid time off
• Continuing education & training

Company Description

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