Regulatory Affairs Specialist

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.