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Medical Device Reporter

  • Location: Tarrytown, New York, 10591
  • Job Type:Contract

Posted 10 days ago

Terrific Contract Opportunity!

Our client is one of the world's largest producers of energy-efficient, resource-saving technologies. Come be a part of how digitalization, globalization, urbanization, demographic change, and climate change are transforming our world.

Position: Medical Device Reporter

Location: Tarrytown New York 10591

Term: 12 months

Day-to-Day Responsibilities:

  • Evaluate safety complaint escalations, make decisions on MDR reporting, and documenting 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 organization's business practices and issues faced and contributions to problem resolution of those issues.

Is this a good fit? (Requirements):

  • 2-3 years of experience with complaint handling and Medical Device Reporting (US and Outside of the US).
  • Good writing, communication and organizational skills necessary.
  • BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience.
  • Certification may be required in some areas.

If this sounds like the perfect fit, apply today!