Clinical Data Analyst III

On-siteSeniorData Analystposted 111mo ago

✦Role summaryAI-generated

This role requires a Clinical Data Analyst III to evaluate Ortho products against Annex II (2017/746) compliance, identifying critical gaps and proposing remediation strategies with cost/resource estimates. The position demands deep expertise in regulatory documentation, performance assessments, and structured reporting for medical device compliance.

Skills required

Regulatory compliance analysis Clinical data assessment Performance evaluation reporting Budget forecasting Annex ii compliance Data gap identification Product classification Technical documentation review Resource estimation Medical device regulatory

About this role

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.

Qualifications

Qualifications:

Experience:

5+ years’ experience in a role in regulated healthcare industry and preferably in a Medical Device/IVD regulated industry
Preferable experience having worked in an R&D or Clinical Affairs role.

Required Competencies:

Experience in technical and clinical data review.
Attention to detail and problem-solving.
Excellent verbal, written and presentation skills.
Ability to work independently

Desired Competencies:

Working knowledge of EU IVD regulations
Working knowledge of IVD products and regulations
Familiarity with web-based content sharing applications (i.e. SharePoint), Microsoft Office Suite, Adobe.