Spec Regulatory Reporting

Medline•Mundelein, IL

18h

About The Position

The Regulatory Reporting Specialist is responsible for product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine Medical Device Reporting (MDR) reportability in alignment with current procedures and regulatory requirements. It ensures MDR submissions comply with FDA reporting requirements, 21 CFR 803, and Quality System regulations.

Requirements

Bachelor’s degree in a relevant field.
At least 1 year of experience in complaint handling, MDR evaluation, post-market surveillance, regulatory affairs, or other relevant experience within a regulated industry.
Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).
Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.
Strong analytical and critical-thinking skills, including the ability to apply updated decision logic consistently.
Effective cross-functional communication and collaboration skills.
Ability to manage multiple priorities and meet strict remediation timelines.
Proficiency with Microsoft Office (Word, Excel, PowerPoint).

Nice To Haves

At least 2 years of experience supporting complaint remediation, MDR reporting, or similar activities in a regulated medical device, pharmaceutical, or healthcare environment.
Experience with large-scale retrospective reviews or high-volume documentation processing.
Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.

Responsibilities

Review new and historical product complaints for data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees.
Evaluate complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic.
Work with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather information needed for accurate reportability assessments.
Prepare and submit MDRs through the FDA electronic submission portal (eMDR) for newly identified reportable events.
Collaborate with international regulatory contacts, when necessary, to determine and support global reporting obligations.

Benefits

Competitive total rewards package.
Continuing education and training.
Health insurance for employees working 30 or more hours per week on average.
Life insurance for employees working 30 or more hours per week on average.
Disability insurance for employees working 30 or more hours per week on average.
401(k) contributions.
Paid time off.
Employee Assistance Program access for employees working less than 30 hours per week.
Employee Resource Groups for employees working less than 30 hours per week.
Employee Service Corp access for employees working less than 30 hours per week.
Bonus and/or incentive eligibility.