We are Hiring - 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
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually as applicable.
Interested candidates can share their resumes to or can call me directly at
Never miss an opportunity! Create an alert based on the job you applied for.