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Quality Professional
5 months ago
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.
