Tarrytown, United States
about 1 month ago
- 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.
- 2-3 years of experience with Medical Device Reporting (US and Outside of the US).
- Good writing, communication and organizational skills necessary.
- Education: BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
Key Working Relationships: Primarily intra organizational contacts and external contacts.