· Evaluate safety complaint escalations, assess and make decisions on medical device reporting [Medical Device Report (MDR)-MedWatch Form 3500A], in accordance with 21 CFR 803, and documenting those decisions.
· File MDRs when needed and communicate (as appropriate) to the EU 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 Laboratory Diagnostics (LD) BA product lines.
· Provide support in all areas associated with Medical Device Report (MDR) / Medical Device Vigilance Report (MDVR) / Medical Device Problem
Report (MDPR-Canada) reporting and trending.
· In addition, support the Commercial Product Quality (CPQ) department when working on post market LD product line issues.
· Provide CPQ support for LD 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.
· Display an understanding of clinical laboratory in-vitro diagnostics testing
· 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 requirment.
Key Working Relationships: Primarily intra organizational contacts and external contacts.
Organization: Siemens Healthineers
Company: Siemens Healthcare Private Limited
Experience Level: Experienced Professional
Full / Part time: Full-time