Manager, Regulatory Compliance – Recalls

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Lead the recall team, offering coaching and professional development.

• Assist in the planning and execution of both voluntary and mandatory recalls, product corrections, and removals in compliance with FDA regulations.

• Participate in recall and field action decision-making, including recommendations for recall strategies.

• Ensure the timely submission of FDA Form 806 along with related documentation, status updates, and termination requests.

• Uphold compliance with 21 CFR Part 7 and 21 CFR Part 806.

• Aid in communications with the FDA and prepare responses related to recalls.

• Monitor regulatory changes concerning field actions and adverse event requirements, escalating any impacts to leadership.

• Track timelines, ensure deliverables are met punctually, and update leadership on progress and potential risks.

• Facilitate and support cross-functional meetings with Quality, Regulatory, and Commercial teams.

• Oversee the daily operations and execution of recall activities.

• Contribute to project and program deliverables.

• Implement and ensure compliance with established policies and procedures.

• Provide direction and guidance to team members.

• Engage in hiring input, performance management, employee development, training, and performance evaluations.

• Allocate work, monitor progress, estimate staffing needs, and ensure consistent application of policies.

⛳️ Requirements

• Bachelor’s Degree in Engineering, Science, or a related field, or an Associate’s Degree accompanied by 3+ years of relevant experience.

• Over 5 years of experience in the medical device or pharmaceutical industry.

• Familiarity with product recalls, complaints, non-conformances, CAPAs, field actions, root cause analysis, and problem-solving techniques.

• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.

• Experience with SAP.

• Minimum of 4 years of experience with FDA regulations, QSR, GMP, ISO requirements, or other regulated sectors.

• At least 3 years of experience managing recalls.

• Solid understanding of FDA regulations including 21 CFR Part 7, Part 806, Part 803, and ISO 13485.

• Experience in supporting recall activities and regulatory submissions.

• Strong project coordination skills.

• Experience with supporting FDA audits or internal quality audits.

• Preferred: More than 5 years of direct experience in recall management.

• Preferred: experience in cross-functional regulatory or quality environments.

🏝️ Benefits

• Competitive total rewards package.

• Opportunities for continuing education and training.

• Eligibility for bonuses and/or incentives.

• Health insurance coverage.

• Life and disability insurance benefits.

• Contributions to 401(k) retirement plans.

• Paid time off.

• Access to Employee Assistance Programs for employees working less than 30 hours per week.

• Participation in Employee Resource Groups.

• Involvement in Employee Service Corps.

• Opportunities for career advancement.

• Access to tools and resources to excel in performance.