Post Market Surveillance Specialist

📋 Description

• Investigating complaints daily: Perform the preliminary classification of complaints and escalate
• Perform Failure Analysis investigation review and escalate complaints that require additional
• 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
• Approve final complaint file for closure after all applicable actions are completed.

🎯 Requirements

• Degree in engineering, life science, or equivalent
• English proficiency required: 85% (spoken and written)
• 2+ years of experience in medical device field
• Knowledge and understanding with Medical Device Complaint files and quality record documentation
• Knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA
• General technical and or clinical medical device knowledge