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3 Month Regulatory Affairs.

West Midlands £35 - £40 per hour

This re-classification means that the company now need help getting the documentation in line with all FDA standards.

General Responsibilities;

  • General guidance on regulatory practice for the re classified device.
  • Technical file writing and updating.
  • Aligning systems from ISO 9001 to 13485.
  • Making all documentation presentable to the FDA.
  • Setting up a system to work to once contract is over.

Required Experience;

  • Proven working Experience with CFR 21.
  • Experience writing technical files and gaining CE marking.
  • Strong understanding of the processes involved in dealing with the FDA.
  • Good understanding of FDA auditing process.

If you believe you have the required skill then please contact me ASAP on 02077587322.

To find out more about Real please visit

19 February 2013
19 March 2013
Joseph Dykes
Full Time
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