Vigilance Writer

Job Summary

To support regulatory compliance and quality initiatives, the remote contract Vigilance Writer will assess complaints, author and approve vigilance reports, and collaborate with cross-functional teams in a fast-paced environment.

Key responsibilities:

• Assess, follow-up, and code complaints globally while managing vigilance activities
• Author and peer review 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 combination of education and experience
• Experience in medical device complaint triage and vigilance reporting
• Knowledge of global vigilance reporting requirements for medical devices
• Proficiency in Microsoft Office and complaint database applications
• Experience dealing directly with regulatory bodies is preferred