Supervisor

Hiring for Supervisor, MDR Remediation We are seeking an experienced Supervisor, MDR Remediation to lead a high-volume team 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, MDR preparation, and submissions while ensuring compliance with 21 CFR Part 803 and FDA reporting requirements. The ideal candidate will have 5+ years of experience in medical device complaint handling, MDR reporting, regulatory compliance, and at least 2 years of people management experience. Strong knowledge of CAPA activities, FDA inspections, and complaint handling systems such as TrackWise or ETQ Reliance is highly preferred.

Location:

Mundelein, IL (3 dayz onsite)

Duration:

3-6

Month Contract Pay Range:

30-35/hr If you have experience leading MDR remediation or post-market regulatory teams in the medical device industry and are interested in learning more, feel free to connect or send your resume. Interested candidates canshare their resumes to eshika.jain@collabera.com or call me at 312-971-8967 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.