Vigilance Writer

Job Summary

To support global product monitoring, the part-time Vigilance Writer will assess and code complaints, author and approve vigilance reports for regulatory submission, and collaborate with internal teams to ensure compliance with medical device industry standards while working remotely.

Key responsibilities

• Assess, follow-up, and code vigilance activities for global complaints
• Author and peer review vigilance reports to ensure timely submissions to regulatory authorities
• Collaborate with engineering and internal staff to support regulatory reporting compliance

Required qualifications

• Bachelor's degree or relevant combination of education and experience
• Demonstrated experience in medical device complaint triage and vigilance reporting
• Strong proficiency in MS Office and complaint database applications
• Direct experience of writing and filing global vigilance reports in the medical device industry
• Working knowledge of global vigilance reporting requirements for medical devices