Manager, Regulatory Compliance – Recalls

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🔥 2 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $116k - $174k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Medline Industries, LP

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1910

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 Private Equity Round on 2021-06

Healthcare • Logistics • Manufacturing

Medline Industries, LP is a leading healthcare company that focuses on improving clinical, financial, and operational outcomes for its customers. The company offers a wide array of over 335,000 medical products and boasts extensive warehousing capabilities with more than 28 million square feet of space. With a significant global presence of 43,000 employees, Medline provides agile and scalable solutions across all points of care, achieving a 95% next-day delivery rate within the US. The company's mission is to enhance healthcare delivery by providing superior products, supply chain resilience, and clinical expertise, all while fostering strong customer relationships through tailored, problem-solving solutions.

📋 Description

• Manage the recall team, providing coaching and development • Support planning and execution of voluntary and mandatory recalls, product corrections, and removals in accordance with FDA regulations • Contribute to recall and field action decisions, including recall strategy recommendations • Ensure timely submission of FDA Form 806 and related documentation, status reports, and termination requests • Maintain compliance with 21 CFR Part 7 and 21 CFR Part 806 • Support communications with FDA and prepare recall-related responses • Monitor regulatory changes related to field actions and adverse event requirements and escalate impacts to leadership • Track timelines, ensure deliverables are completed on schedule, and update leadership on progress and risks • Facilitate and support cross-functional meetings with Quality, Regulatory, and Commercial teams • Oversee day-to-day operations and execution of recall activities • Support project and program deliverables • Implement and ensure adherence to policies and procedures • Provide direction and guidance to team members • Participate in hiring input, performance management, employee development, training, and performance reviews • Assign work, monitor progress, estimate personnel needs, and ensure consistent policy application

🎯 Requirements

• Bachelor’s Degree in Engineering, Science, or related field, or Associate’s Degree with 3+ years of experience • 5+ years of experience in the medical device or pharma industry • Experience with product recalls, complaints, non-conformances, CAPAs, field action, root cause analysis, and problem solving • Experience with Microsoft Office Suite, including Word, Excel, and PowerPoint • Experience with SAP • At least 4 years of experience with FDA, QSR, GMP, ISO requirements, or other regulated industries • At least 3 years of experience in recall management • Working knowledge of FDA regulations including 21 CFR Part 7, Part 806, Part 803, and ISO 13485 • Experience supporting recall activities and regulatory submissions • Strong project coordination skills • Experience supporting FDA audits or internal quality audits • Preferred: 5+ years of direct experience with recall management • Preferred: experience working in cross-functional regulatory or quality environments

🏖️ Benefits

• Competitive total rewards package • Continuing education & training • Bonus and/or incentive eligibility • Health insurance • Life and disability insurance • 401(k) contributions • Paid time off • Employee Assistance Program access for employees working less than 30 hours per week • Employee Resource Groups • Employee Service Corp • Career growth opportunities • Tools and resources to perform at their best