Safety Assurance Case

South Wales  ‐ Onsite
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Keywords

Description

The RA Associate's day to day activities will include;
  • Work closely with process development teams to integrate Safety Assurance activities into product development processes
  • Construct Safety Assurance Case for Product offerings
  • On-going maintenance of Safety Assurance Case
  • Construct and maintain the Risk Management File
  • Liaise directly with FDA and government agencies to ensure structure and management of the Safety Assurance case is as expected.
  • Create and provide on-going educational material regarding change control and the effects upon SAC and RMF
  • Facilitate SAC and RMF sessions as part of design change process flow.
  • Review standards / requirements to ensure compliance. Analysis of standards and design and liaising with design engineers where relevant.

Essential Requirements;
  • Experience of creating and maintaining Safety Assurance cases and supporting documentation
  • Analytical approach
  • Be able to work independently and as part of a team showing good inter-personal and information transfer skills.
  • Looks beyond boundaries of own job to support others.
  • Demonstrates a positive attitude to change and contributes to new ideas and improved ways of working.
  • Demonstrate sound work ethics.


If you believe you have the right level of experience for this role, and wish to discuss this further, then please contact Joseph Dykes on .

To find out more about Real please visit www.realstaffing.com
Start date
07/2013
Duration
6 Months
From
Real Staffing
Published at
29.05.2013
Project ID:
543078
Contract type
Freelance
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