Global Product Monitoring Vigilance Report Writer (remote)
Insulet
US
Base: $69,000.00 - $103,500.00; bonus/equity: may ...
Medical device complaint triage
Vigilance reporting expertise
Post-market surveillance
The Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices to meet customer, regulatory, and client requirements
Job Summary
The Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices to meet customer, regulatory, and client requirements.
This role is responsible for global complaint assessment, coding, vigilance activities, and authoring vigilance reports to ensure timely submissions to regulatory authorities.
Insulet offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, paid time off, and wellness programs.
Matching Summary
The Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices to meet customer, regulatory, and client requirements.
Salary
Base: $69,000.00 - $103,500.00; Bonus/Equity: May be eligible for incentive compensation; Benefits: Medical, dental, vision insurance, 401(k) with company match, PTO, wellness programs
Skills & Requirements
Must-have
medical device complaint triage
vigilance reporting expertise
post-market surveillance
regulatory reporting compliance
quality management system knowledge
complaint coding and follow-up
Nice-to-have
effective verbal and written communication
analytical and detail oriented
interpersonal skills
ability to influence without authority
experience with global vigilance requirements
experience dealing with regulatory bodies
Key Requirements
Bachelor’s degree or equivalent experience
experience in medical device complaint triage and vigilance reporting
clinical experience in diabetes disease management or diabetes device support
direct experience writing and filing global vigilance reports
working knowledge of multi-country vigilance reporting requirements
BSN with diabetes experience or Registered/Licensed Dietician or Diabetic Educator preferred