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Regulatory Post Mkt Surveillance Analyst

2 months ago

Sunnyvale, United States Intuitive Surgical Full time
Job Description

Primary Function of Position: The Regulatory Post Market Surveillance Analyst captured complaints, investigates customer complaints, makes initial reporting judgments, files regulatory reports, and ensures completeness and consistency of complaint documentation.

Roles and Responsibilities: This position has responsibility and authority for:

  • Investigating complaints daily:
    • Complaint intake and triage for reportability
    • 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 examine lot documentation (DHRs) to establish if there are any anomalies that maybe related to reported product failures.
  • Escalate complaints to the Regulatory Post Market Surveillance Manager or senior team members 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