5+ years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industryĀ Strong working knowledge of FDA Medical Device Reporting regulations (21 CFR 803) and complaint handling requirements (21 CFR 820.198)Ā Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500AĀ Ability to evaluate complaint narratives, determine reportability, and apply FDA coding for adverse events, malfunctions, injuries, and deathsĀ Strong verbal and written communication skills with the ability to collaborate effectively across Quality, Regulatory Affairs, R&D, and Operations teamsĀ Experience with quality documentation processes, verification activities, DMR/DMRC documentation, and HIPAA-compliant recordkeepingĀ Proficiency with MSĀ Suite and complaint management systems such as SAP, TrackWise, or similar platformsĀ Bachelorās degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Healthcare, or a related field Mission:Ā 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.