Vigilance Report Writer

Job Summary

A company is looking for a Vigilance Writer to develop and maintain quality assurance methodologies in alignment with regulatory requirements.

Key Responsibilities

• Assess, follow up, code, and manage global vigilance activities for complaints
• Author, peer review, and approve vigilance reports for timely submission to regulatory authorities
• Collaborate with cross-functional stakeholders to ensure regulatory compliance and support internal audits

Required Qualifications

• Bachelor's degree or equivalent combination of education and experience
• Experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes management
• Strong proficiency in MS Office and complaint database systems
• Solid understanding of medical device Quality Management Systems (QMS)
• Experience writing and submitting global vigilance reports