Newark, United States
8 months ago
Job description - Evaluate safety complaint escalations and make decisions on Medical Device Reporting (MDR), fully documenting those decisions. File MDRs when needed and communicate as appropriate to the Authorized Representative or Regional Unit. Work with the Designated Complaint Handling Unit (DCU) and Medical Affairs to review and assess and close potentially adverse events (pMDRs), including MDR reporting related to Atellica/Dimension systems /Dimension Vista systems and assays/Informatics systems.
Provide support in all areas associated with MDR/MDVR/MDPR reporting and trending.
In addition, support the Commercial Product Quality department when working on post market Atellica/Dimension/Dimension Vista systems and assays and Informatics system related issues from the Escalation Review Council (ERC).
Provide Commercial Product Quality support for the above mentioned systems Product Health Teams.
Provide Commercial Product Quality support for external audits (LRQA, FDA, etc.).
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, issues faced and contributions to problem resolution of those issues.
Experience in Quality Systems and Medical Device Reporting.
Education: BS/BA in Medical Technology, Biomedical Engineering or related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
Good writing, communication and organizational skills necessary.
Key Working Relationships: Primarily intra organizational contacts and external contacts.