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