Rachele Carter Email and Phone Number

Daily activities of assessing an average of 50 cases per day. Assessing for documentation quality and global regulatory reportability requirements, for image guided therapy systems and devices. Performing follow-up and closure activities when needed.

• Subject matter expert on reporting adverse events and product complaints to the FDA• MDR writing team lead during FDA field action and recall.• Run nightly mitigation reports and daily morning matrix• Facilitated multiple departments events (i.e. Christmas party, JDRF fundraising & department involvement/inspirational isle)• Valued team member on multiple collaboration projects◦ Department survey improvement project◦ Test group for improvements on soon to be released complaint system software◦ Multiple special closure project teams

• Report Product complaints to the FDA• Manage and distribute workload for two complaint teams• Facilitated training for new MDR writers to assist in a high volumes, due to a FDA field action.

• Organized close to one half a million reports in preparation to for storage.• Processed over 800 customer complaints through first review. (Bringing the code at hand current within 10-days)• Trained in the "Data Investigation Process" for sensor failure.• Educated on FDA Title 21 Sec. 803 Medical Device Reporting

Input books online for text book store. Maintain competitive pricing and current inventory. Package and ship books to distributing warehouse.

Worked with A/R report for multiple doctors, checking payment status, mostly for Medi-Medi accounts. Researched denials and resubmitted corrected claims.

Managed student files, test scores and certification records for military students. Created and posted resumes for clients in seek of employment. Updated and designed flyers, brochures and other marketing recruitment products for the company.

Package dental implant attachments. Boxed, labeled and shipped orders out to customers. Opened, received and distributed incoming mail, along with starting the process of any returns or warranty products.

Worked with the team of crew members in charge of product placement and signing.