Spec Regulatory Reporting

Medline Industries, LP•Mundelein, IL

2d•$67,000 - $101,000

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 that MDR submissions comply with FDA reporting requirements under 21 CFR 803 and applicable Quality System regulations.

Requirements

Bachelor’s degree in a relevant field and 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 requirements under 21 CFR 803 and complaint handling requirements under 21 CFR 820.198.
Ability to interpret medical descriptions, product information, and complaint narratives to assess event severity and regulatory obligations.
Strong analytical and critical-thinking skills, including the ability to consistently apply updated decision logic.
Effective cross-functional communication and collaboration skills.
Ability to manage multiple priorities and meet strict remediation timelines.
Proficiency with Microsoft Office, including Word, Excel, and 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 alignment of reportability decisions with current regulatory standards, internal procedures, and decision trees.
Evaluate complaint files under 21 CFR 803 using current criteria, definitions, and decision logic to determine MDR reportability.
Work with Quality, Regulatory Affairs, R&D, Operations, and other internal partners to gather missing complaint or product information for 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
Life insurance
Disability insurance
401(k) contributions
Paid time off
Employee Assistance Program access for employees working less than 30 hours per week on average
Employee Resource Groups access for employees working less than 30 hours per week on average
Employee Service Corp access for employees working less than 30 hours per week on average
Bonus and/or incentive eligibility