Manager Regulatory Compliance - Recalls
$116,000–$174,000 year
RemoteNorthfield, Illinois, United States
Job Summary
Manage the recall team, providing coaching and development for individual contributors and supervisors. Support the 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, including status reports and termination requests. Maintain compliance with 21 CFR Part 7 and 21 CFR Part 806. Support communications with the FDA and assist in preparing responses related to recalls. Monitor regulatory changes related to field actions and adverse event requirements, escalating impacts to leadership. Track timelines and ensure deliverables are completed on schedule. Facilitate and/or support cross-functional meetings to ensure alignment across stakeholders, including Quality, Regulatory, and Commercial teams.
Required Qualifications
- Bachelor's Degree in Engineering, Science, or related field or Associates Degree with 3+ years experience
- 5+ years of experience in the medical device or pharma industry
- experience with product recalls, complaints, non-conformances, CAPAs, or similar activities involving field action, root cause analysis and problem solving
- Experience with Microsoft Office Suite (Word, Excel, PowerPoint)
- Experience with SAP
- At least 4 years of experience working 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 communication and project coordination skills
- Experience supporting FDA audits or internal quality audits
Desired Qualifications
- 5+ years of direct experience with recall management
- Experience working in cross-functional regulatory or quality environments
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