Product Surveillance Analyst

Job Summary

A company is looking for a Product Surveillance Analyst II.

Key Responsibilities:

• Review and process adverse events and product complaints, assessing seriousness and reportability
• Prepare and submit FDA MDRs and support international regulatory reporting within required timelines
• Conduct complaint investigations and collaborate with cross-functional teams to ensure product quality and safety

Required Qualifications:

• Associate's degree or Bachelor's degree required
• 3+ years of experience in post-market surveillance or complaint handling in the medical device/pharmaceutical industry required
• At least 1 year of experience with FDA MDR and international regulatory reporting preferred
• Working knowledge of 21 CFR Part 820 and 21 CFR Part 803 preferred
• Familiarity with medical device regulations and post-market surveillance processes