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Job Description
Title:
Regulatory Affairs Specialist Location:
Mundelein, IL Duration:
3 to 6 Months Pay range: $25/hr to $30/hr
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:
Bachelor's degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Healthcare, or a related field 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 Office Suite and complaint management systems such as SAP, TrackWise, or similar platforms 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.
