Regulatory Post Market Surveillance Analyst, Level II and III

Location: Sunnyvale, CA

Summary:

The Regulatory Post Market Surveillance Analyst investigates customer complaints, makes an initial reporting decision, files malfunction reports and ensures completeness and consistency of complaint documentation.

Job Description:

  • 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 compliant 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 may be related to reported product failures
  • Escalate complaints to the Regulatory Post Market Surveillance Manage 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

Requirements:

  • Undergraduate degree in Engineering, Life Science or equivalent
  • 2 to 4+ years of experience in medical device field with experience in the following areas:
    • Knowledge and understanding of Medical Device Complaint files and quality record documentation
    • Knowledge and understanding of Regulatory reporting requirements for Medical Device (US FDA requirements, EU MDD requirements etc.)
  • Demonstrate strong written and verbal communication skills
  • Strong computer skills (Excel, Word, PowerPoint, database)
  • Demonstrate cross functional communication skills in email and in person
  • Ability to handle and manage workload independently
  • Contribute to team oriented tasks
  • Firm understanding of Regulatory reporting requirements for Medical Device and complaint system and process requirements
  • Firm understanding of quality records requirements and how they apply to complaint files
  • Familiarity with world-wide regulatory reporting requirements
  • Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary