Product Complaint Analyst I

Product Complaint Analyst I

The Product Complaint Analyst I will work in a fast-paced environment to analyze customer complaints for the Urology Complaint Management Center (CMC) to determine which are regulatory reportable. Will be responsible for adherence to Good Documentation Practices (GDP) and required processing of complaint handling records per the Code of Federal Regulations (21CFR) and International regulatory agencies. In addition, will initiate follow up with field sales representatives, end use customers and complaint investigation site to obtained additional event details, as applicable. Communicates event investigation results via regulatory reports and written communications, as appropriate. Products within scope include but are not limited to men's prosthetic urology, prostate health, and surgical lasers.

Your responsibilities will include :

• Dispositioning of events that meet complaint criteria
• Accurately performs regulatory assessment
• Files regulatory reports within country respective timelines.
• Follows up with customer, physician and sales representative for additional information as applicable.
• Coordinate and collaborates with the complaint investigation site for on time completion of event investigations in order to meet regulatory report filing due dates.
• Issues customer response letters, closes complaint files and documents objective evidence for audit readiness.
• Follows implemented policies and procedures to ensure compliance with appropriate statues and regulations.
• Participates in department system improvement projects while able to manage assigned work to achieve Urology monthly metric objectives.

Required qualifications :

Preferred qualifications :

Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.