Senior Vigilance Report Writer

Job Summary

A company is looking for a Senior Global Product Monitoring Vigilance Report Writer (Remote/Flexible).

Key Responsibilities:

• Assess, follow-up, code, and manage vigilance activities for high-priority complaints
• Author, peer review, and approve vigilance reports for regulatory submissions
• Collaborate with internal teams to ensure compliance with regulatory reporting standards

Required Qualifications:

• Bachelor's degree with 5 years of experience in medical device complaint triage and vigilance reporting or related clinical experience
• Demonstrated experience in medical device complaint handling and vigilance reporting
• Experience writing and filing global vigilance reports in the medical device industry
• Knowledge of global vigilance reporting requirements and regulatory body interactions
• Preferred qualifications include a BSN with diabetes experience or credentials as a Registered Dietician or Diabetic Educator