Adverse Event Specialist jobs in United States
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Insight Global · 3 days ago

Adverse Event Specialist

positionMundelein, IL
timeFull-time
remoteHybrid
seniorityEntry Level
money$28/hr - $32/hr
date1+ years exp

Insight Global is seeking an Adverse Event Specialist to support their regulatory affairs efforts. The role involves reviewing product complaints for regulatory compliance and collaborating with various internal teams to ensure accurate reporting decisions.

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H1B Sponsor Likelynote

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

Qualification

Complaint handlingRegulatory affairsMedical device reportingAnalytical skillsCross functional communicationTime managementFDA regulations knowledgeComplaint management systems

Required

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

Preferred

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, TrackWise, or similar platforms

Company

Insight Global

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Insight Global provides top talent and staffing solutions that help job seekers find careers in healthcare, finance, IT, and government.
dateFounded in 2001
location
Atlanta, Georgia, USA
people-size1001-5000 employees
web-link
https://insightglobal.com/

H1B Sponsorship

Insight Global has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (281)
2024 (164)
2023 (75)
2022 (17)
2021 (3)
2020 (2)

Funding

Current Stage
Late Stage
Total Funding
unknown
2010-07-01Acquired

Leadership Team

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Jared Streppa
President Of Company’s Technology Division
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Recent News

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2025-09-26
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2025-09-23
Company data provided by crunchbase