Adverse Event Specialist

Insight Global (United States); Mundelein (IL); On-site; USD 40,000 - 57,000; Full time

Job summary

Insight Global is seeking an Adverse Event Specialist in Illinois to support product complaint remediation and MDR processing. The role involves reviewing historical and new complaints, determining MDR reportability, and ensuring FDA requirements and Quality System regulations are met.

Collaboration with Quality, Regulatory Affairs, and other teams is essential. The position emphasizes strict reporting timelines, cross-functional communication, and detailed documentation to support global

Qualifications

• Bachelor’s degree in a relevant field.
• 2+ years of experience in complaint handling, MDR evaluation, post-market surveillance, regulatory affairs, or related work.
• Experience within a regulated pharmaceutical or medical device environment.
• Ability to review medical descriptions, product information, and complaint narratives to determine event severity and reporting requirements.
• Strong analytical and critical-thinking skills with the ability to consistently apply regulatory decision logic.
• Strong organization and time-management skills to meet strict reporting timelines.
• Effective cross-functional communication skills.

Responsibilities

• Review new and historical product complaints for completeness and regulatory reportability.
• Evaluate complaint files using current procedures, regulatory criteria, and decision trees.
• Determine MDR reportability under 21 CFR 803 and document reporting decisions.
• Prepare and submit reportable events through the FDA’s electronic MDR submission process.
• Partner with Quality, Regulatory Affairs, R&D, Operations, and other teams to obtain missing complaint or product information.
• Support retrospective complaint remediation and high-volume documentation reviews.
• Collaborate with international regulatory contacts when needed to support global reporting obligations.

Skills

Regulatory reporting

Analytical thinking

Cross-functional communication

Time management

Event severity assessment

Education

Bachelor's degree

Tools

TrackWise

SAP

Job description

Pay Rate: Up to $35/hr

Duration: 6-month contract-to-hire

Required Skills & Experience

• Bachelor’s degree in a relevant field
• 2+ years of experience in complaint handling, MDR evaluation, post-market surveillance, regulatory affairs, or related work
• Experience within a regulated pharmaceutical or medical device environment
• Ability to review medical descriptions, product information, and complaint narratives to determine event severity and reporting requirements
• Strong analytical and critical-thinking skills with the ability to consistently apply regulatory decision logic
• Strong organization and time-management skills to meet strict reporting timelines
• Effective cross-functional communication skills

Nice to Have Skills & Experience

• Understanding of FDA Medical Device Reporting requirements under 21 CFR 803 and complaint handling requirements under 21 CFR 820.198
• Experience with high-volume documentation processing or large-scale retrospective complaint reviews
• Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms
• Experience preparing or submitting MDRs, MedWatch reports, ICDTs, or similar regulatory reports

Job Description

An established medical device company is seeking an Adverse Event Specialist to support product complaint remediation and the processing of new complaints. This role will review historical and newly received complaints, determine MDR reportability, and ensure applicable reports are completed in accordance with FDA requirements, 21 CFR 803, and Quality System regulations.

• Review new and historical product complaints for completeness and regulatory reportability.
• Evaluate complaint files using current procedures, regulatory criteria, and decision trees.
• Determine MDR reportability under 21 CFR 803 and document reporting decisions.
• Prepare and submit reportable events through the FDA’s electronic MDR submission process.
• Partner with Quality, Regulatory Affairs, R&D, Operations, and other teams to obtain missing complaint or product information.
• Support retrospective complaint remediation and high-volume documentation reviews.
• Collaborate with international regulatory contacts when needed to support global reporting obligations.