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