Description
Regulatory Affairs Consultant Medical Devices £55 - £60ph Immediate StartMedical devices client in thenorth westis looking for a senior regulatory affairs consultant for the development, verification, validation of, and post-market support for, in vitro companion diagnostic medical devices.
You will be responsible for joint project team global regulatory operations and company-wide clinical consultancy.
Regulatory submissions US and EU: pre-IDE, MAF, IDE, PMA, Technical Files
Clinical affairs and regulatory compliance
Sole responsibility for FDA Bioresearch Monitoring (BIMO) inspection
Support for FDA PAI (quality) audit
You MUST have experience with the above and extensive regulatory affairs experience within medical device companies.
Regulatory Affairs Consultant Medical Devices £55 - £60ph Immediate Start
Please contact Steven Ruddy from Real Pharma - Medical Devices on
To find out more about Real please visit www.realstaffing.com