SUMMARY

Responsible for receiving, reviewing and processing all product inquiries for complaint evaluation as required by applicable regulations, standards, and company policy. This position requires understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211).

 ESSENTIAL/PRIMARY DUTIES:

Responsible for receiving, reviewing and processing all product inquiries for complaint evaluation as required by applicable regulations, standards, and company policy. 

Helps provide customer support and serve as a liaison between manufacturing facilities, distribution centers, customer/technical service and customers regarding product complaints.

This role also partners with Quality Engineering on product investigations and trends.Direct interface with Customers, and Internal Teammates for reporting of complaints and adverse events. (This may include complaint intake and/or follow-up requests for information.

Understand the complaint handling process from initiation to closure.

Process and close complaints in a timely manner.Analyze and trend CC data, prepare charts for reporting to mgmt.

Prepare for and attend MDR team meetings on behalf of the Complaint Handling Unit.

Handle reporting Initial and Supplemental MDRs.

Maintain current knowledge of the FDA regulations (frequent reading of the trade press/emails, FDA news bulletins, attending job-related webinars, or outside courses when appropriate); consider innovative solutions to meet changing regulatory compliance goals.