Prabu Jayabal

About Prabu Jayabal

I have 8+ years of experience in the Quality Assurance and Regulatory Affairs Health…

Experience

1. Mdr Vigilance Specialist (Cyient)

   Medtronic

   Jul 2024 — Present · Hyderabad, IN

   Investigated customer complaints, conducted root cause analysis developed corrective actions & Preventive action (CAPA).> Evaluate incoming complaint information and maintain the record in the electronic database.> Performs follow-up activities to obtain additional information. Use and maintain databases, provide analysis and trending data all on complaints.Determine reportability of complaints to government agencies.> Identify and document appropriate complaint categories to ensure trend accuracy within the complaints database.> Writes investigation summaries based on technical product analysis information provided.> Ensure record documents are maintained in a constant state of audit readiness per internal policies.> Liaison with groups who perform additional investigation and who prepare written record of investigation.> Interact with Technical services, Manufacturing, R&D, and Quality Assurance, as needed, during complaint processing.> Provide basic technical expertise and assistance in handling complaints to comply with current FDA and international reporting regulations.> Reviews and interprets Risk management documents as it applies to the complaint event.> Interact with multiple departments within Medtronic - MITG, such as technical services, failure investigation, R&D, Manufacturing, and Engineering.Interact with groups internal to Medtronic - MITG such as customers, vendors, and healthcare professionals.> Work within the Case Review, Reassessment, and Investigation team to accurately document customer-reported product complaints.> Critically Review complaint details to ensure all relevant information has been received to determine report ability based on regulatory requirements.> Experience with adequate and accurate review of DHF and DMR documents.