Vigilance Writer

Job Summary

A company is looking for a Vigilance Writer to develop and maintain quality assurance methodologies in the medical device industry.

Key Responsibilities

• Assess, follow-up, code, and manage vigilance activities for global complaints
• Author and approve vigilance reports for timely submissions to regulatory authorities
• Collaborate with internal teams to ensure compliance with regulatory reporting standards

Required Qualifications

• Bachelor's degree or relevant education and experience
• Experience in medical device complaint triage and vigilance reporting or clinical diabetes management
• Strong proficiency in Microsoft Office and complaint database applications
• Direct experience with global vigilance reporting requirements for medical devices
• Experience interacting with regulatory bodies is highly desired