Title: Adverse Event Specialist
Location: Hybrid Mundelein, IL (Onsite Tuesday Thursday; Remote Monday and Friday)
Duration: 3 6 months
Pay Range : $28 to $30 per hour
Benefits:
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 , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - As Applicable
Why is this open: Additional support is needed to manage product complaint remediation activities, conduct retrospective complaint reviews, and ensure timely Medical Device Reporting (MDR) compliance in alignment with FDA regulations and internal quality standards.
Mission: Support post-market surveillance and regulatory compliance efforts by reviewing product complaints, determining MDR reportability, and ensuring all adverse event submissions are completed accurately and in accordance with FDA requirements, including 21 CFR 803 and Quality System regulations.
Day-to-Day: Collabera is looking for an Adverse Event Specialist to review both new and historical product complaints to assess data completeness and determine MDR reportability. This individual will apply current regulatory guidance, decision trees, and internal procedures to evaluate adverse events and identify reportable malfunctions, injuries, or deaths. The specialist will prepare and submit MDRs through the FDA eMDR portal, including completion of FDA Form 3500A and assignment of appropriate FDA codes. The role will partner closely with Quality, Regulatory Affairs, R&D, and Operations teams to obtain missing information, ensure accurate documentation, and maintain compliance with HIPAA requirements. Additional responsibilities include supporting large-scale remediation efforts, conducting verification activities, and collaborating with global regulatory teams as needed to meet reporting obligations.
Must Haves:
- 5+ years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry
- Strong working knowledge of FDA Medical Device Reporting regulations (21 CFR 803) and complaint handling requirements (21 CFR 820.198)
- Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A
- Ability to evaluate complaint narratives, determine reportability, and apply FDA coding for adverse events, malfunctions, injuries, and deaths
- Strong verbal and written communication skills with the ability to collaborate effectively across Quality, Regulatory Affairs, R&D, and Operations teams
- Experience with quality documentation processes, verification activities, DMR/DMRC documentation, and HIPAA-compliant recordkeeping
- Proficiency with MS Suite and complaint management systems such as SAP, TrackWise, or similar platforms
- Bachelor s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Healthcare, or a related field
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