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Risk analyst

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Risk analyst

Pharmaceuticals

Frankfurt am Main, Hessen

Description

Risk Analyst


Our client is a leading provider of healthcare services to millions of customers around the world. They require a risk analyst in the Pharma or Medical device industry to provide gap analysis and review of risk analysis, research, preparation of a evaluation of supplier Risk documentation.

Role will include:

Gap Analysis of new standards
Review and update of use risk analysis on study-based data
Review and update of Usability Engineering planning documents
Review and update of Usability Engineering report document
Creation of reports based on external documentation (usability study report, research or analysis reports



Experience

Scientific or engineering degree with a minimum of 3-5 years of experience in the medical device or pharma industry, preferably in a risk management or quality environment position for drug delivery systems
Strong hands-on background expertise in the application of relevant ISO standards such as ISO 13485, 14971, 62366
Experience with FDA regulations such as 21 CFR 4 and 21 CFR 820 for drug delivery systems
Ability to prepare technical reports
Fluency in written and spoken English and German essential

This will be for a 24 month engagement
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Job Details

  • Job Type:

    Contract
  • Rate:

    Negotiable
  • Job published:

    11 days ago
  • Reference:

    BBBH8536