Global Product Monitoring Vigilance Report Writer
Core
Develops and maintains quality assurance methodologies for post-market vigilance and complaint handling in the medical device industry, ensuring regulatory compliance and on-time reporting to authorities.
Role type
Senior IC Medical Device Vigilance Specialist
Builds
Global vigilance reports and complaint coding systems for medical devices
Domain
Medical Devices / Regulatory Compliance
Required skills
Medical device complaint triage, vigilance reporting, regulatory authority interaction, quality management systems, data analysis, report authoring and peer review
Preferred skills
Diabetes disease management experience, diabetes device support, experience with Prestataires, BSN or Registered Dietitian certification
Technologies
Microsoft Office (Excel, Word, Outlook), complaint database applications
Responsibilities
Assess, follow-up, and code global complaints; author and approve vigilance reports for regulatory submission; support management in daily operations; collaborate with engineering and lab staff on event reviews; support team training and mentorship; serve as SME for regulatory inquiries; assist with internal/external audits.
Seniority
Senior, hands-on IC
