MDR Regulatory Reporter — FDA Compliance & Analysis

Regulatory Jobs; Mundelein (IL); On-site; USD 67,000 - 101,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Employee Resource Groups

Job summary

Medline Industries, LP seeks a Regulatory Reporting Specialist to assess product complaints for MDR reportability and to ensure submissions meet FDA 21 CFR 803 and Quality System requirements.

The role collaborates with Quality, Regulatory Affairs, R&D, and Operations to collect information and submit MDRs via the FDA eMDR portal. Strong regulatory knowledge and data interpretation are essential.

Qualifications

• Bachelor’s degree in a relevant field plus 1+ year in complaint handling or regulatory affairs.
• Familiarity with FDA MDR requirements and 21 CFR 803 is preferred.
• Ability to interpret medical descriptions and determine event severity.

Responsibilities

• Review new and historical product complaints to verify data completeness and reportability.
• Evaluate complaints to determine MDR reportability under 21 CFR 803 using current criteria.
• Collaborate with Quality, Regulatory Affairs, R&D, and Operations to gather missing information.
• Prepare and submit MDRs through FDA’s eMDR portal for reportable events.
• Coordinate with international regulatory contacts to support global reporting obligations.

Skills

Regulatory interpretation

Analytical thinking

Cross-functional collaboration

Data interpretation

Regulatory decision logic

Time management

Microsoft Office proficiency

Education

Bachelor’s degree in a relevant field

Tools

TrackWise

SAP

Job description

Medline Industries, LP seeks a Regulatory Reporting Specialist to assess product complaints for MDR reportability and to ensure submissions meet FDA 21 CFR 803 and Quality System requirements.

The role collaborates with Quality, Regulatory Affairs, R&D, and Operations to collect information and submit MDRs via the FDA eMDR portal. Strong regulatory knowledge and data interpretation are essential.