Supervisor

Title:

Supervisor, MDR Remediation (FDA 483 Response)

Location:

Mundelein, IL Duration:

3-6 Months Pay range: $35-$38

Day-to-Day:

Collabera is looking for a Supervisor, MDR Remediation to lead and manage a team of 20-25 employees supporting retrospective Medical Device Reporting (MDR) activities in response to FDA 483 observations. This individual will oversee end-to-end remediation workflows, including reportability assessments, investigations, data gathering, MDR preparation, and submissions, while ensuring compliance with 21 CFR Part 803, SOP-00048, and FDA reporting guidance. The Supervisor will establish team priorities, monitor throughput and quality metrics, provide real-time coaching and performance feedback, and serve as the escalation point for complex regulatory cases. Additional responsibilities include driving process standardization, supporting CAPA activities, maintaining audit readiness, collaborating cross-functionally with Clinical, Regulatory, and Quality teams, and ensuring all remediation timelines and submission requirements are met in a fast-paced environment.

Must Haves:

5+ years of experience in medical device complaint handling, MDR reporting, or regulatory compliance 2+ years of direct people management experience Strong knowledge of 21 CFR Part 803 and MDR requirements Experience with complaint handling systems such as ETQ Reliance or TrackWise Experience supporting FDA inspections and CAPA activities The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually - as applicable.