Vigilance Writer

Job Summary

A company is looking for a Vigilance Writer.

Key Responsibilities:

• Assess, follow-up, code, and manage vigilance activities for global 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 or relevant combination of education and experience
• Experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes management
• Proficiency in Microsoft Office and complaint database applications
• Knowledge of medical device Quality Management Systems and global vigilance reporting requirements
• Experience interacting with regulatory bodies is preferred