Complaint Handling Specialist

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.