Vigilance Report 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 with global vigilance reporting requirements
• Preferred qualifications include a BSN with diabetes experience or a background as a Registered Dietician or Diabetic Educator