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 timely regulatory submissions
• Collaborate with internal teams to ensure compliance with regulatory reporting standards

Required Qualifications:

• Bachelor's degree and 5 years of relevant experience in medical device complaint triage or diabetes management
• Experience in writing and filing global vigilance reports in the medical device industry
• Knowledge of global vigilance reporting requirements and country-specific regulations
• Experience dealing with regulatory bodies is preferred
• Strong understanding of a formalized medical device Quality Management System