Global Product Monitoring Vigilance Report Writer (remote)

Insulet Corporation

Base: $69,000.00 - $103,500.00; bonus/equity: elig...
Medical device complaint triage
Vigilance report writing and filing
Post-market vigilance expertise
The Global Product Monitoring Vigilance Report Writer serves as a subject matter expert to improve awareness and communication on quality and compliance initiatives supporting corporate quality goals

Job Summary

  • The Global Product Monitoring Vigilance Report Writer serves as a subject matter expert to improve awareness and communication on quality and compliance initiatives supporting corporate quality goals.
  • This role involves authoring, peer reviewing, and approving vigilance reports to ensure timely submissions to regulatory authorities and collaborating with cross-functional teams to maintain compliance.
  • The company offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) with company match, paid time off, and employee wellness programs.

Matching Summary

The Global Product Monitoring Vigilance Report Writer serves as a subject matter expert to improve awareness and communication on quality and compliance initiatives supporting corporate quality goals.

Salary

Base: $69,000.00 - $103,500.00; Bonus/Equity: Eligible for incentive compensation; Benefits: Medical, dental, vision insurance, 401(k) match, PTO, wellness programs

Skills & Requirements

Must-have

  • Medical device complaint triage
  • Vigilance report writing and filing
  • Post-market vigilance expertise
  • Regulatory reporting compliance
  • Quality Management System knowledge
  • Complaint coding and investigation

Nice-to-have

  • Strong Microsoft Office proficiency
  • Effective verbal and written communication
  • Analytical and detail oriented
  • Interpersonal and influencing skills
  • Experience with global multi-country reporting
  • 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 device support
  • Direct experience writing global vigilance reports
  • Knowledge of country-specific regulatory requirements
  • Preferred BSN, Registered or Licensed Dietician, or Diabetic Educator

Work Rights

Not specified

Tailored Resume

Cover Letter