Curtis Christian

• Reviewed complaint files, confirmed accurate device codes, and determined reportability.

• Reviewed product investigations and updated codes based on investigation results.

• Performed final review of reportable files, prepared regulatory reports for submission.

• Trained and led team for complaint review project identifying inconsistency in decisions and documentation.

• Documented information for product malfunctions and adverse events involving transcatheter heart valves.

• Made complaint determination, applied necessary medical codes, and conducted communication to obtain additional information needed for regulatory reporting, investigation, and company trending.

• Made reportability decisions, prepared and submitted regulatory reports to the FDA and EU.

• Led meetings discussing potential late reports, determined and documented appropriate action.

• Led problem solving team, conducted meetings, documented progress throughout the life cycle of problems.

• Made complaint determinations and reportability decisions for medical events involving non-implantable cardiac monitors and network applications. Prepared and submitted regulatory reports.

• Processed incoming information for medical events involving implantable pacemaker systems.

• Used QMS system to document event details including writing description of the event, applying applicable medical codes, and completed investigations.

• Led training team for new complaint handling team members.

• Evaluated and processed customer complaints for implanted urological devices.
• Used TrackWise system to document initial reportability decision, add applicable medical codes.
• Verified and entered new product information and patient records into a database.

• Evaluated medical device allegations and complaints for events involving implanted drug delivery systems.
• Processed product events and prepared information for reporting determination and investigations.
• Conducted follow-up by phone, fax, and email to obtain additional information needed for reportability decisions, investigations, and trending purposes.

• Spoke with healthcare providers about products, lab tests, and alternative options for therapy to help personalize additional heath care options for the patient.
• Documented feedback, complaints, and reporting of adverse events, which required understanding the regulatory requirements of FDA, HIPAA, and CLIA.
• Worked with sales and marketing to create content and ensure quality and accuracy of scientific writing.