Complaints Handler

**Job Description: Complaint Handling Specialist**

**Key Responsibilities**:

- **Complaint Creation and Documentation**:

- Initiate and create detailed records of complaints in the system.
- Review complaint records across ancillary systems for relevant information related to the reported issue.
- **Complaint Analysis and Coding**:

- Analyze the nature of the complaint to determine if further escalation is required.
- **Decision Making**:

- Utilize decision trees to assess the reportability of complaints.
- Ensure the accurate completion of decision-making processes and documentation.
- **Regulatory Reporting**:

- Conduct domestic vigilance reporting, including Medical Device Reports (MDRs).
- Complete global vigilance reporting, such as Medical Incident Reports (MIRs).
- **Complaint Resolution**:

- Manage the closure process for both reportable and non-reportable complaints, ensuring all relevant documentation is complete and accurate.
- **Compliance and CAPA**:

- Support Corrective and Preventive Action (CAPA) processes by analyzing data from complaints and identifying trends for process improvements.
- Collaborate with cross-functional teams to implement CAPA measures and track their effectiveness.

**Qualifications**:

- Bachelor’s degree in a relevant field (e.g., Life Sciences, Nursing, Biomedical Engineering).
- Minimum of [X] years of experience in a complaint handling or quality role within the medical or healthcare industry.
- Demonstrated experience with CAPA processes is mandatory.
- Strong knowledge of domestic (MDRs) and global (MIRs) vigilance reporting.
- Proficiency in analyzing complaint data and identifying areas for escalation.
- Excellent attention to detail and ability to manage multiple tasks effectively.
- Strong communication skills and ability to work collaboratively across teams.

**Preferred Skills**:

- Familiarity with regulatory guidelines and standards relevant to the medical and healthcare industry.
- Experience using quality management systems and complaint handling software.

**Work Environment**:

- This role may require occasional collaboration with cross-functional teams and participation in meetings or reviews related to CAPA and regulatory compliance.

Pay: ₹300,000.00 - ₹800,000.00 per month

Schedule:

- Day shift
- Monday to Friday

**Experience**:

- total work: 3 years (required)

Work Location: In person