Spec Regulatory Reporting

Medline Industries, Inc. in; Mundelein (IL); Presencial; USD 67.000 - 101.000; Jornada completa

Descripción de la vacante

Medline Industries, LP is seeking a Regulatory Reporting Specialist to manage MDR determination and complaint remediation. You will review historical and new complaints for reportability under FDA rules, ensuring 21 CFR 803 compliance and proper data capture.

You will work with Quality, Regulatory Affairs, R&D, and Operations to gather required information and submit MDRs electronically. Prior MDR/regulated industry experience is preferred.

Formación

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

Responsabilidades

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

Educación

Bachelor’s degree in a relevant field

1+ year of experience in complaint handling/MDR evaluation/regulatory affairs

Herramientas

SAP

TrackWise

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.

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 / Skill / 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‑functional 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. 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.

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.

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.

Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time. If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. To learn more about how Medline makes healthcare run better, visit www.medline.com.