Regulatory Reporting Specialist

Regulatory Jobs; Mundelein (IL); Presencial; USD 67.000 - 101.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Employee Resource Groups

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory interpretation

Analytical thinking

Cross-functional collaboration

Data interpretation

Regulatory decision logic

Time management

Microsoft Office proficiency

Educación

Bachelor’s degree in a relevant field

Herramientas

TrackWise

SAP

Descripción del empleo

Job Summary

The Regulatory Reporting Specialist is responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations.

Job Description

Responsibilities

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

Minimum Job Requirements

Education & Work Experience

• Bachelor’s degree in a relevant field AND 1+ year of experience in complaint handling, MDR evaluation, post-market surveillance, regulatory affairs, or other relevant experience within a regulated industry.

Knowledge / Skills / Abilities

• 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 with the ability to apply updated decision logic consistently.
• Effective cross-functionally communication and collaboration skills.
• Ability to manage multiple priorities and meet strict remediation timelines.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint).

Preferred Job Requirements

• 2+ years of experience supporting complaint remediation, MDR reporting, or similar activities within a regulated medical device, pharmaceutical, or healthcare environment.
• Experience working in environments requiring large-scale retrospective reviews or high-volume documentation processing.
• Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.
• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

The anticipated salary range for this position:

$67,000.00 - $101,000.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

For a more comprehensive list of our benefits please click here.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.