QA Manager

My client based in theMidlandsis looking for a quality assurance manager who has experience of working within a regulated environment such as medical device, pharmaceutical.

The ideal candidate would have experience working within these industries and candidates with academic experience in biomechanics, biochemistry or any similar medical discipline would be at an advantage. In depth knowledge of ISO 9001/13485 and Medical Device Directive 93/42/EEC is essential, and experience of FDA 21 CFR Part 820 will be extremely beneficial.

Experience Required:
* Preparing and administering an FDA 510k submission
* Prepared and created CE Technical Files
* Preparation and support of regulatory submissions
* Experience of carrying out clinical literature reviews for medical devices

Please do forward this email to any friends or colleagues that may be looking. We offer £200 worth of vouchers if the candidate is placed successfully.

For a full job specification or if you would like to discuss the position in more detail please call Tasmin Choudhury on 0207 758 7322 and send your up to date CV

To find out more about Real Staffing please visit www.realstaffing.com