Complaint Specialist, Sr.

• 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 course of complaint investigation.
• Serves as informal resource for team members.
• Serves as 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 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.

• 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