Job description

One of our clients is looking for a talented and highly motivated MDR Complaint Analyst/Engineer. Please send your resume if you want to pursue this opportunity and authorize Infosoft to represent you for this position.

Here are the job position details for your review:

Job Title: MDR Complaint Analyst/Engineer
Pay Rate: $30 to 31.24/Hr
Duration: 12 Months
Location: Tarrytown, NY

This position is for the Healthcare Diagnostics division.

Job description:

• Evaluate safety complaint escalations, make decisions on MDR reporting, and document those decisions.
• File MDRs when needed and communicate (as appropriate) to the Authorized Representative or Regional Unit.
• Work with members of other teams to review, assess, and close potentially adverse events (pMDRs), including MDR reporting related to IMMULITE systems/ADVIA Chemistry systems/ADVIA Centaur Systems/Automation/ Dimension systems / Dimension Vista systems/Informatics systems.
• Provide support in all areas associated with MDR/MDVR/MDPR reporting and trending.
• In addition, support the Commercial Product Quality (CPQ) department when working on post-market IMMULITE systems/ADVIA Chemistry systems/ADVIA Centaur Systems/Automation/ Dimension systems / Dimension Vista systems/Informatics systems related issues from the Escalation Review Council (ERC).
• Provide CPQ support for the above-mentioned systems' Product Health Teams.
• Display of a high level of critical thinking in bringing successful resolution to high-impact, complex, and/or cross-functional problems is expected.
• Demonstrate a significant knowledge of the organization's business practices and issues faced and contribute to problem resolution of those issues.

Requirements:

• 2-3 years of experience with complaint handling and Medical Device Reporting (in the US and Outside of the US).
• Good writing, communication, and organizational skills are necessary.

Education:

• BS/BA in a related discipline, or advanced degree, where required, or equivalent combination of education and experience.
• Certification may be required in some areas.

Job Types: Full-time, Contract

Salary: $31.00 - $31.24 per hour

Schedule:

• 8 hour shift

Experience:

• complaint handling and Medical Device Reporting: 1 year (Required)

Work Location: Remote

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