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Regulatory Post Market Surveillance Analyst
hace 3 meses
Primary Function of Position:
The Regulatory Post Market Surveillance Analyst investigates customer complaints, makes initial reporting decisions, files regulatory reports, and ensures completeness and consistency of complaint documentation.
Roles and Responsibilities:
This position has responsibility and authority for:
- Investigating complaints daily:
- Perform the preliminary classification of complaints and escalate complaints that require additional review.
- Perform Failure Analysis investigation review and escalate complaints that require additional review.
- File Malfunction MDR Reports as identified
- Escalate Adverse Event or Incident reports to Level IV Analysts as identified
- Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file.
- Approve final complaint file for closure after all applicable actions are completed.
- Manage complaint workload to required backlog goals.
- Review and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.
- Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered.
Escalate complaints with potential related product failures to the Post Market Investigation (PMI) group
- Evaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements.
- Interface with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA
- Create customer response letters upon request
- Provide peer review and feedback of complaints and reports
- Participate in new hire training and continuous Regulatory Compliance training as required
- Participate in process improvement activities to continuously improve process effectiveness
- Execute on projects as required
- Perform other duties as directed
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