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, 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
• Knowledge of medical device Quality Management Systems
• Experience writing and filing global vigilance reports in the medical device industry
• Familiarity with global vigilance reporting requirements for medical devices