Post-Market Surveillance Analyst

Job Summary

A company is looking for a Post Market Surveillance Analyst.

Key Responsibilities

• Monitor and assess the quality of complaint records for compliance with regulations and standards
• Prepare daily workflow reports to support timely processing and closure of complaints
• Act as a subject matter expert during regulatory audits and coordinate projects for operational support

Required Qualifications

• 3-5+ years of experience in quality, manufacturing, or regulatory roles within an FDA regulated industry
• Strong analytical skills and ability to derive data from enterprise systems
• Knowledge of FDA 21 CFR Part 820, ISO Standards, and Global Tobacco Regulations
• Bachelor's degree in a relevant field such as science, engineering, or safety
• Prior experience in medical device or pharmaceutical complaint handling is preferred