Global Vigilance Report Writer

Global Product Monitoring – Vigilance Report Writer Pay Rate: $45/hour Remote Position Position Overview Our client is seeking a Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical‑device industry best practices that meet customer, regulatory, and internal requirements. This role serves as a post‑market vigilance and surveillance subject matter expert, improving awareness, visibility, and communication on quality and compliance initiatives. The position involves working on problems of diverse scope, requiring strong analytical judgment and collaboration with senior internal and external personnel.

Key Responsibilities

• Global Complaint Assessment — Assess, follow up, code, and perform vigilance activities for global complaints.
• Vigilance Report Writing — Author, peer‑review, and approve vigilance reports to ensure timely submission to regulatory authorities.
• Operational Support — Support management in daily operations and ensure proper coding of complaints and reportable events.
• Cross‑Functional Collaboration — Work with engineering, investigation labs, medical teams, and other internal groups to review events, coding, and investigation results.
• CAPA Participation — Contribute to departmental non‑conformances escalated into the CAPA system.
• Subject Matter Expertise — Serve as SME for post‑market and complaint‑handling regulatory questions.
• Audit Support — Support internal and external audits and inspections.
• Special Projects — Assist with assigned projects with minimal supervision.
• Perform additional duties as required.

Minimum Requirements

• Bachelor’s degree or equivalent combination of education and experience.
• Demonstrated experience in medical‑device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support.

Preferred Skills & Competencies

• Strong proficiency with Microsoft Office and complaint database applications.
• Effective verbal and written communication skills.
• Ability to generate, verify, and maintain accurate records.
• Strong analytical skills, attention to detail, and interpersonal skills.
• Demonstrated ability to influence without authority.
• Strong organizational skills with the ability to prioritize and escalate appropriately.
• Solid understanding of formal medical‑device Quality Management Systems.
• Direct experience writing and filing global vigilance reports.
• Working knowledge of global, multi‑country vigilance reporting requirements and country‑specific differences.
• Experience interacting directly with regulatory bodies (highly desired).
• BSN with diabetes experience, Registered Dietician, Licensed Dietician, or Diabetes Educator (preferred).

Travel & Physical Requirements

• General office environment; prolonged sitting may be required.
• Extensive computer use.
• Up to 10% travel may be required.