Supervisor MDR Remediation

Clerk Supervisor, MDR Remediation (FDA 483 Response)

Duration: 6 Months of contract

Location: Mundelein, IL, 60060 (HYBRID - 3 Day Onsite)

Pay Range: $35/hr - $40/hr

Day-to-Day:

• Looking for a Supervisor, MDR Remediation, 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.

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
• Bachelor's degree in a scientific, engineering, or related field

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, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable