MDR Vigilance Specialist
- Medtronic
- 4 - 9 years
- Hyderabad
- 10 days ago
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Job Description
- 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 Government Agencies.
- Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.
- Writes investigation summaries based on technical product analysis information.
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 regulations.
- Reviews and interprets risk management documentation as it applies to the complaint event.
- Interacts with multiple departments within Medtronic - MITG, such as Technical Services, Failure Investigation, R & D, Manufacturing and Engineering.
- Interacts with groups external to Medtronic - MITG, such as customers, vendors, health care professional
- Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety and effectiveness of medical devices.
- Evaluates for reporting criteria to Government Agencies to determine if the event reasonably suggests a device may have or could have caused or contributed to a death or serious injury.
Required knowledge and experience:
- Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety and effectiveness of medical devices.
- Evaluates for reporting criteria to Government Agencies to determine if the event reasonably suggests a device may have or could have caused or contributed to a death or serious injury.
Job Classification
Industry: Medical Services / HospitalFunctional Area / Department: Risk Management & ComplianceRole Category: Assessment / AdvisoryRole: Risk AnalystEmployement Type: Full timeContact Details:
Company: MedtronicLocation(s): Hyderabad
Keyskills: Medical devices Manager Quality Assurance Technical services Complaint handling Product analysis Investigation Database Healthcare Risk management Auditing
Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.We challenge ourselves and each other to make tomorrow better than yesterday. It is what mak...
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