Events Specialist

Adverse Event Specialist

Location: Mundelein, IL (Hybrid – Onsite Tuesday–Thursday, Remote Monday & Friday)

Duration: 3-6 months

Pay Range: 25-30/hr

We are seeking an Adverse Event Specialist to support product complaint reviews and Medical Device Reporting (MDR) activities. This role will be responsible for evaluating complaints, determining reportability, and ensuring compliance with FDA regulations and internal quality standards.

Responsibilities:

• Review product complaints and adverse events for MDR reportability
• Evaluate complaint data for completeness and accuracy
• Prepare and submit MDRs in accordance with FDA requirements (21 CFR 803)
• Complete FDA Form 3500A and assign appropriate FDA codes
• Collaborate with Quality, Regulatory Affairs, R&D, and Operations teams to obtain missing information
• Maintain accurate documentation and support remediation activities
• Ensure compliance with HIPAA and quality system requirements

Requirements:

• 5+ years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs
• Experience with Medical Device Reporting (MDR) and FDA regulations (21 CFR 803)
• Experience preparing and submitting MDRs, including FDA Form 3500A
• Knowledge of complaint handling requirements (21 CFR 820.198)
• Experience with complaint management systems such as SAP, TrackWise, or similar tools
• Strong communication and documentation skills
• Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, Healthcare, or a related field