at Chronos Imaging LLC in Aurora, Illinois, United States
Job Description
Interface with FDA, EU or other Health Authorities regarding medical device product defects and safety evaluations. Prepare and submit technical file dossiers for approval by regulatory agencies for medical devices. Communicate and interface with Regulatory agencies regarding status of submissions. Prepare responses to requests from Regulatory Agencies. Work with Engineering and other regulatory Engineers throughout the product life cycle to monitor and maintain post-market product compliance, including risk review, clinical impact, review of similar products in the field, and factors involving state-of-the-art. Lead Complaint team investigators responsible for evaluating, investigating, and resolving complaints to ensure compliance with government agency regulatory requirements. Complete an initial assessment of reportability and escalate to the manager when necessary to determine regulatory reportability/safety action. Analyze complaint data reporting, gather additional data as needed, and partner cross-functionally with Design Development and Manufacturing teams on potential product improvements for regulatory compliance. Stay up to date on regulatory rules and updates. ****Work is at Employer’s headquarters office located at 555 N. Commerce Street, Aurora, IL 60504 with no travel involved.
