Complaint Handler
2 weeks ago
1. Identification of Reportable and Not Reportable events.
2. Submission of Medical device Reports( MDR) and Medical Device Vigilance Report (MDVR)
3. Awareness about basic Medical Regulatory standards (13485,14971,21CFR(803) etc)
4. Hands on experience must on MDR reporting and submission to Regulatory Authorities (Any one ex: US, EU, Canada...)
5. Overall 2 to 5 yrs exp in Medical domain in (PMS, complaint handling, Pharmacovigilance and MDR Reporting
6. As per regulation, creating the MedWatch 3500 form for the incident such as Adverse event and malfunction submission to FDA
7. Evaluating the complaints, incident analysis, investigating, Analysis of root cause of adverse event, malfunction of device and implementation of corrective action.
**Tools knowledge :Track wise, SAP, Web Trader, E-submitter.**
QARA, MDR Reporting, EU MDR Reporting, Vigilance Reporting, MDR submission, Complaint Handling. **- MANDATORY.**
**Tools knowledge**:Track wise, SAP, Web Trader, E-submitter.
**Job Types**: Full-time, Regular / Permanent
**Salary**: ₹80,000.00 - ₹90,000.00 per year
Ability to commute/relocate:
- Mysore, Karnataka: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 4 years (required)
