Global Product Monitoring Vigilance Report Writer
Core
Develops and maintains quality assurance methodologies and systems for post-market vigilance and surveillance of medical devices; serves as a subject matter expert for reportable events and regulatory compliance.
Role type
Senior IC Medical Device Vigilance Report Writer
Builds
Post-market vigilance reports and regulatory submissions for medical device clients
Domain
Medical Devices / Pharmacovigilance
Required skills
Medical device complaint triage, vigilance reporting, regulatory compliance knowledge, data analysis, quality management system (QMS) understanding
Preferred skills
Diabetes disease management experience, diabetes device support, global multi-country vigilance reporting requirements, regulatory body interaction
Technologies
Microsoft Office (Excel, Word, Outlook), complaint database applications
Responsibilities
Assess, follow-up, code, and manage vigilance activities for global complaints; author, peer review, and approve vigilance reports for regulatory submission; support management in day-to-day operations; collaborate with engineering and laboratory staff to review events and investigation results; support training and mentorship of post-market team members; serve as SME for regulatory questions; support internal and external audits and inspections.
Seniority
Senior, hands-on IC
