Clinical Data Analyst III - Rochester, NY
5 days ago
Job summary
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.
- 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.
Responsibilities
- 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.
Qualifications
- 5+ years' experience in a role in regulated healthcare industry and preferably in a Medical Device/IVD regulated industry
-Attention detail problem-solving.
-Excellent verbal written presentation skills.
-Ability work independently,
Job description
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