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p>CORA Physical Therapy provides a full range of outpatient services for clients with orthopedic problems, work-related injuries, sport injuries, and neuromuscular and neurological conditions. Works closely and supports operations to deliver digital services and meet patient care and staffing needs.
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 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.
The specialist will prepare and submit MDRs through the FDA eMDR portal, including completion of FDA Form 3500A and assignment of appropriate FDA codes. Collabera is looking for an Adverse Event Specialist to review both new and historical product complaints to assess data completeness and determine MDR reportability.
Building on a century of innovation, our 48,000 associates help deliver comprehensive science-based solutions, data-driven insights and world-class service to advance food safety, maintain clean and safe environments, and optimize water and energy use, and improve operational efficiencies and sustainability for customers in the food, healthcare, life sciences, hospitality and industrial markets in more than 170 countries around the world.