Description
My client is a Medical device company in the north west of England. They are now looking for a Quality Assurance Manager to manage the Quality Assurance function in line with relevant cGMP, FDA QSR 21 CFR 820, ISO13485 and European Medical Device Directive MDD 94/42/EEC as amended, and to be the companies Representative for Quality.- Prepare and submit European (CE Marking) and FDA (510k) applications for the authorisations to market new products
- Establish and maintain relationships with regulatory authorities including the MHRA and Notified Bodies regarding clinical trials and submissions
- Liaise with internal stakeholders on the changing regulations and how these will impact the business
- Assist the Quality Team on hosting audits and partaking in internal audits
- Ensure regulatory compliance from design and development through to vigilance and post market activities.
Skills/Experience
- Several years working in the Medical Device/IVD market
- Experienced in CE Marking a product
- Ideally class III medical device experience, however, this is not essential
- Ideally 510(k)/FDA experience
I am currently arranging interviews for this position so if you believe you have the correct experience and are keen on joining an exciting new business then please send me your CV and I will be in touch shortly.