Adverse Event Specialist

Overview

Location
:
Mundelein, IL (3x days onsite T-Th, hybrid)

Duration
: 6-month contract, possible extension or hire

Pay Rate
: $28-32/hr

Requirements:

• Bachelor's degree in a relevant field.
• 1+ year of experience working in complaint handling, MDR evaluation, post market surveillance, regulatory affairs, or other relevant experience.
• Ability to interpret medical descriptions, product information, and complaint narratives to determine event severity and regulatory obligations.
• Experience in a regulated industry (pharmaceutical / medical device / food and beverage industry).
• Strong analytical and critical thinking skills with the ability to apply updated decision logic consistently.
• Strong time management skills to meet strict timelines, cross functional communication skills, and critical thinking skills.

• Basic understanding of FDA Medical Device Reporting (21 CFR 803) and complaint handling requirements (21 CFR 820.198).
• Experience working in environments requiring large scale retrospective reviews or high volume documentation processing.
• Familiarity with complaint management systems such as SAP, Track Wise, or similar platforms.

• 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.