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Quality Assurance and Regulatory Affairs Associate

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Posted By: Conceptuality
Address:
Contact: 02920 020 120
Date Posted: 22nd Jul 2008
Salary: £25000 - £30000 per annum
Location: Swansea
Reference Code: J2897
Views Since Posting: 91
Full Description:

My client is a innovative Medical Device company, with a recent business win they are now recruiting for a Quality Assurance and Regulatory Affairs Associate.

We are looking for imaginative, independent minded individuals with a passion for innovation and a desire to work as part of a motivated team in a challenging and rewarding environment. We currently have a vacancy for a Quality Assurance and Regulatory Affairs Associate. You will be working with the Quality Assurance and Regulatory Affairs Manager on the quality and regulatory aspects for the company's miniature infusion products, to ensure compliance with FDA and ISO standards.

Other duties within this key role will include:
Conducting internal audits.
Advising the product development team of quality and regulatory compliance standards.
Developing and maintaining product technical files.
The suitable candidate will have previous experience of implementing and working with quality management systems within a medical device environment. A vast amount of experience of working to ISO 13485 standards is required for this position. Experience of working with infusion products or electro-mechanical medical devices is highly advantageous but not essential for this role.

Conceptuality People Solutions Ltd is acting as an Employment Agency in relation to this vacancy.