Job Title: Clinical Data Analyst III
Location: Rochester, NY 14626
Duration: 1 year
Responsibilities:
- The Responsibilities: Based on the classification assessment of the Ortho products undertake an assessment of a sample of different classes of product against the Technical Documentation (Annex II - 2017/746) and identify any gaps and in particular significant gaps.
- From the representative product sample identify the time and resources required to address any gaps that can be used for budget planning purposes in 2018/19, particularly if product testing or performance evaluations are required.
- Create draft Performance Evaluation reports for a representative sample of Class B, C and D products.
- Propose opportunities for filling any identified gaps with data from other sources such as published literature, post-market data.
- Provide periodic updates to the IVDr Project Lead at a frequency to be determined.