Associate Medical Device Reporting Vigilance Specialist

Role Overview

In this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for company products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. You will also compile regulatory agency reports for submission and monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow‑up actions that pertain to complaint closure.

• Document and evaluate product feedback and product analysis results for company products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines.
• Compile regulatory agency reports for submission in accordance with US and OUS regulatory reporting criteria.
• Monitor complaint activity to ensure timely review of product feedback, product analysis, and product formal investigation, and any associated follow‑up actions that pertain to complaint closure.
• Apply policies and procedures to comply with FDA and OUS regulations.
• Monitor the company’s drug or medical devices surveillance program including intake, protocol development, evaluation, processing, and follow‑up on adverse event reports, complying with government regulations.
• Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
• Ensure complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.

• Strong attention to detail.
• Strong analytical skills (problem solving, critical thinking).
• Proficient at evaluating and synthesizing product feedback and analysis results.

Bachelor’s degree.

A few months to 2 years of experience. Prefer some job experience but open to interviewing recent graduates.