Regulatory Affairs (RA/QA) Consultant MD/IVD's £65ph North 6 months
My client in the North is looking for a senior regulatory affairs consultant for the development, verification, validation of, and post-market support for, in vitro companion diagnostic.
You will be responsible to oversee and perform all RA/QA activities relating to IVD devices for in preparation for a PMA / FDA site inspection.
CE marking Technical File development activities undertaken (i.e. Risk Assessments to ISO 14971:2009, Essential Requirements to Annex I, Label artwork to EN980:2008 / EN1041:2008, Clinical Summary Evaluations Report developed.
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 MD/IVD's £65ph North
Please contact Steven Ruddy from Real Pharma - Medical Devices on 0207 758 7322
To find out more about Real please visit www.realstaffing.com