3 Month Regulatory Affairs.

Dudley
£35 - £40 per hour
19 Feb 2013
19 Mar 2013
RE-12451846
Joseph Dykes
Engineering
Contract
Full Time

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 www.realstaffing.com