Complaint Handling Specialist

2 weeks ago

Pune, India Tata Elxsi Full time

KEY JOB REQUIREMENTS: In this role, you will be successful, if you have:

Qualification
• Bachelor or Master of Science, preferably: Biomedical, Mechanical Engineering, Biotechnology, Biochemistry, Pharmacy or similar

Experience:
• At least 3 to 5 years of experience including experience in leading teams and managing daily operations, preferably in complaint management


• Experience in complaint database such as SAP, Trackwise, Salesforce etc.


• Holds knowledge of monitoring and tracking of report submission in accordance with related standards, regulatory timelines


• Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint)

Key Responsibilities


• Medical devices Complaint handling- Complaint processing including Complaint Intake, Product details, Triage, Decision tree, Complaint closure


• Vigilance reporting


• IMDRF and FDA codings


• Complaint investigation


• Due diligence


• Mailbox monitoring and handling Responsibilities may include the following and other duties may be assigned


• Evaluates incoming complaint information and maintains the record in the electronic database.
• Performs follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data all on complaints.


• Determines Reportability of complaints to regulatory bodies.


• Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.


• Writes investigation summaries based on technical product analysis information provided


• Prepare and submit the MedWatch-3500A Report, MIR Report, Initial, Follow-up, and Final Reports to the respective competent authorities in compliance with regulations, guidelines, and the required timeframe.


• To check the customer feedback and initiate follow-up for additional information


• Performed coding activities on the assigned projects with timelines and efficiency.


• Assure the accuracy, integrity, completeness, and consistency of all product complaint investigations of MDR and other Vigilance reports.


• Have clear understanding of KPIs.


• Diligently follow relevant SOP of the project


• Understanding the Responsibility of Timely Escalation of significant events to the Team Lead/Manager.


• Performed QC on all types of records and other related duties as directed by management


• Ensures record documentation is 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 Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.


• Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting Tools Expertise TrackWise, SAP, Salesforce, Microsoft applications (Excel, PowerPoint)

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