SUMMARY:

The Vigilance Specialist is responsible for

Assessing for Adverse Events (AEs) and completing complaint records in a timely manner.
Reporting of AEs to relevant regulatory authorities within the required timelines
Reporting and co-ordination of FCAs both internal and external within the required timelines

ESSENTIAL DUTIES AND RESPONSIBILITIES

Evaluate incoming complaints through various paths.
Ensure all complaint information/data is accurately captured.
Maintain the complaint record in the PLM.
Performs follow up activities to obtain additional information.
Liaise with Engineering to provide investigation report.
Document investigation results based on technical analysis provided.
Ensure record documentation is maintained in a state of audit readiness.
Interact with Technical Service, Manufacturing, R&D;, and Quality Assurance, as needed, during the course of complaint processing.
Identify and document appropriate complaint categories to enable trend accuracy.
Review and interpret risk management files and assign appropriate hazards.




Perform appropriate evaluation steps to ensure all available information is present so to determine.
complaint reportability
Coordinate Adverse Event Reporting and Field Corrective Action processes.

Assist with the Product Correction and Removal process.
Coordinate group meetings to ensure that all tasks have been assigned and completed.

Collect and report metrics to support Management Review and process improvement activities.
Maintain training for Quality System procedures related to the role which can affect the quality of products or services provided to our customers.
Effective team member, fully motivated to achieve and demonstrate best practices in line with the goals of the quality department.
Support/Drive Quality System related project activity as required.
Supports the activities associated with preparing the QMS to maintain certification to MDSAP (FDA, MDR, ANVISA and other regulations) as well as ISO13485:201

📌 Post Market Quality Analyst (Bengaluru)
🏢 Natus Sensory
📍 Bengaluru