Regulatory Affairs Specialist

Adverse Event / Regulatory Affairs Specialist

Location: Mundelein, IL

Contract Length: 6 months

Work Arrangement: Onsite

Pay Rate: $28–$40/hr

Overview

Insight Global is seeking an Adverse Event / Regulatory Affairs Specialist to support a leading medical device manufacturer in Mundelein, IL. This role is responsible for evaluating product complaints, determining regulatory reportability, and ensuring compliance with FDA Medical Device Reporting (MDR) requirements. The specialist will review both historical and newly submitted complaints, prepare MDR submissions, and collaborate cross‑functionally to uphold regulatory and quality system standards.

This position is well‑suited for candidates with foundational regulatory or clinical knowledge who are eager to grow their career in post‑market surveillance and regulatory affairs.

Required Skills & Experience

• Bachelor’s degree in a scientific, clinical, engineering, or related field.
• 1–3 years of relevant experience in any of the following (internships, co‑ops, academic projects, or early‑career roles accepted):
• Complaint handling
• Post‑market surveillance
• Regulatory affairs
• Quality assurance
• Clinical or healthcare environments
• Ability to interpret medical terminology, clinical narratives, and product information.
• Strong analytical and critical‑thinking skills with the ability to follow structured decision logic.
• Excellent time‑management skills and comfort working with deadlines.
• Strong written and verbal communication skills for cross‑functional collaboration.

Preferred Skills & Experience

• Familiarity with FDA Medical Device Reporting (21 CFR 803) and Complaint Handling (21 CFR 820.198).
• Experience with large‑scale retrospective complaint reviews or high‑volume documentation processing.
• Exposure to complaint management systems such as SAP, TrackWise, or similar platforms.
• Clinical background (BSN, RN, or similar), especially in high‑acuity settings such as ICU, PCU, ER, or OR.
• Prior experience in a regulated industry (medical device, pharmaceutical, biotech, food & beverage, etc.).

Key Responsibilities

• Review new and historical product complaints to verify data completeness and ensure reportability decisions align with regulatory requirements and internal procedures.
• Assess complaint files to determine MDR reportability under 21 CFR 803, applying established criteria and decision logic.
• Collaborate with Quality, Regulatory Affairs, R&D, Operations, and other internal teams to gather missing information needed for accurate assessments.
• Prepare and submit MDRs through the FDA’s eMDR electronic submission portal for all newly identified reportable events.
• Support communication with international regulatory partners, when applicable, to meet global reporting obligations.