Senior Recall & FDA Compliance Lead

Medline Industries, LP; Mundelein (IL); On-site; USD 32,000 - 47,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Mundelein, IL seeks a Senior Recall Specialist to lead complex recall activities under FDA regulations. You will coordinate sub-recalls, manage regulatory communications, and guide Recall Specialists to ensure timely, compliant recall execution.

The role requires 3–5 years in regulated recall/quality roles, strong documentation, and collaboration with QA, regulatory teams, and operations. The company offers a comprehensive benefits package and growth opportunities.

Qualifications

• Regulatory recall experience or similar regulated environment preferred.
• Ability to manage complex recall activities and regulatory inquiries.
• Strong documentation and audit readiness practices.

Responsibilities

• Lead and coordinate sub-recall and company-initiated recalls in line with FDA regulations.
• Serve as SME for recall execution and regulatory timelines.
• Respond to FDA effectiveness checks and inquiries with clear documentation.
• Coordinate communications between the company and FDA district office.
• Oversee returned product areas and ensure compliant processing of recalled product.
• Issue return labels, RGAs, credits, and replacements as needed.
• Maintain audit-ready recall records and generate status reports.

Skills

Regulatory compliance

Stakeholder communication

Attention to detail

Training & mentoring

Cross-functional collaboration

Education

High School Diploma or GED

Associate or Bachelor’s degree preferred

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Job description

Medline Industries, LP in Mundelein, IL seeks a Senior Recall Specialist to lead complex recall activities under FDA regulations. You will coordinate sub-recalls, manage regulatory communications, and guide Recall Specialists to ensure timely, compliant recall execution.

The role requires 3–5 years in regulated recall/quality roles, strong documentation, and collaboration with QA, regulatory teams, and operations. The company offers a comprehensive benefits package and growth opportunities.