Job Description

Top 3 things the manager is looking for in a candidates experience:

1. strong attention to detail
2. strong analytical skills (problem solving, critical thinking)
3. strong writings skills

What are the top 3 Tasks or Responsibilities in scope for this role:

1. document and evaluate product feedback and product analysis results for company products to determine complaint status
2. compile regulatory agency reports for submission
3. monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation

Education Required: Bachelor’s

Years’ Experience Required: a few months-2 years’ experience. Prefer some job experience but open to interviewing recent graduates.

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. In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission. As part of complaint closure activities this individual performs activities to 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.

Responsibilities include the following but not limited to:

• Apply policies and procedures to comply with FDA and OUS regulations.

• Monitors the company's drug or medical devices surveillance program including the 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.

• Ensures 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.

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