Kolkata, West Bengal, India
Medical Device Complaint Evaluator: Evaluation of data (complaints, Inquiries, Non-product issues) of the medical devices entered by the affiliates or distributors based on the customer provided descriptions. Identifying and addition of allegation failures or defects of the devices reported based on this analysis in the complaints system. Based on the evaluation determine if the failure represents any adverse event/serious injury or reportable defect which needs to be further escalated for reporting to FDA as per 21 CFR 803(Medical Device Reporting). Medical Device Complaint Investigator: Investigates and processes product complaints while maintaining compliance with all regulations. Skilled in sending customer feedback response letter informing results of product complaint investigation to ensure customer satisfaction. Ensure timely closure of complaints to comply with FDA requirements and other regulatory bodies and countries. Ensures record documentation is maintained in a constant state of audit readiness per internal policies.