Glidewell
Prismatik Position
Essential Functions: Evaluates event(s) to determine if it qualifies as a complaint. Maintains and completes complaint files for all customer complaints according to procedures. Assesses complaint information provided; conducts additional investigations and escalates complaint to appropriate parties as needed. Compiles adverse event investigation information; summarizes investigation, production analysis, imaging review, instructions for use (IFU), and other relevant labeling and/or training materials; formulates conclusions. Interfaces with customers and collaborates with various departments and management. Manages customer relationships and expectations during the course of complaint investigation. Serves as an informal resource for team members. Serves as a subject matter expert (SME) of Quality Systems for complaint handling and regulatory reporting. Monitors complaints regulatory reporting requirements to ensure timeliness of submissions. Monitors, evaluates, and reports on complaint product, and investigations. Evaluates complaints for adverse event reporting as applicable. Verifies comprehensive content of draft MDR reports prior to submission of Form 3500A to FDA. Verifies decisions for "Vigilance report not required" and "MDR report not required" determinations. Closes complaint files when necessary. Reviews potential reportable events to determine if regulatory filings are required. Submits Regulatory Reports for US and OUS. Ensures compliance with all federal and international regulations applicable to manufactured medical devices. Coordinates escalation to Medical Reviewer(s) for decisions regarding potential for serious injuries based on assessed risks. Escalates complaints when new failure modes are encountered. Maintains awareness of new products and government regulations and requirements. Documents and completes complaints in a timely manner. Prepares and submits final customer correspondence as required. Reviews analysis reports; prepares summary reports. Performs other related duties and projects as business needs require at direction of management. Education and Experience: Bachelor's degree in science, engineering, or equivalent relevant experience preferred. Minimum four (4) years of experience within regulatory affairs or medical documentation and reporting. Advanced medical device experience involving medical device complaint files and quality records required. Advanced understanding and interpretation of domestic and international complaint handling and reporting requirements required. Pay Range: $32.00 to $42.00/hr
Essential Functions: Evaluates event(s) to determine if it qualifies as a complaint. Maintains and completes complaint files for all customer complaints according to procedures. Assesses complaint information provided; conducts additional investigations and escalates complaint to appropriate parties as needed. Compiles adverse event investigation information; summarizes investigation, production analysis, imaging review, instructions for use (IFU), and other relevant labeling and/or training materials; formulates conclusions. Interfaces with customers and collaborates with various departments and management. Manages customer relationships and expectations during the course of complaint investigation. Serves as an informal resource for team members. Serves as a subject matter expert (SME) of Quality Systems for complaint handling and regulatory reporting. Monitors complaints regulatory reporting requirements to ensure timeliness of submissions. Monitors, evaluates, and reports on complaint product, and investigations. Evaluates complaints for adverse event reporting as applicable. Verifies comprehensive content of draft MDR reports prior to submission of Form 3500A to FDA. Verifies decisions for "Vigilance report not required" and "MDR report not required" determinations. Closes complaint files when necessary. Reviews potential reportable events to determine if regulatory filings are required. Submits Regulatory Reports for US and OUS. Ensures compliance with all federal and international regulations applicable to manufactured medical devices. Coordinates escalation to Medical Reviewer(s) for decisions regarding potential for serious injuries based on assessed risks. Escalates complaints when new failure modes are encountered. Maintains awareness of new products and government regulations and requirements. Documents and completes complaints in a timely manner. Prepares and submits final customer correspondence as required. Reviews analysis reports; prepares summary reports. Performs other related duties and projects as business needs require at direction of management. Education and Experience: Bachelor's degree in science, engineering, or equivalent relevant experience preferred. Minimum four (4) years of experience within regulatory affairs or medical documentation and reporting. Advanced medical device experience involving medical device complaint files and quality records required. Advanced understanding and interpretation of domestic and international complaint handling and reporting requirements required. Pay Range: $32.00 to $42.00/hr