RA/QA Manager - IVD start up (closed)
My client is a start up biotechnology devices company specialising in real time PCR for a variety of commercial and clinical applications. They are looking to bring in a talented individual with regulatory affairs and quality assurance experience to assist them in moving onto the next phase of their development. With a robust product in late stage development this organisation prides itself on technology and innovation. With extensive financial backing from a major Pharma company they are 18-24 months away from what is likely to be a highly successful product launch.
You will have experience with device technical files and have ideally taken an IVD product to market. In addition you should have negotiated with health authorities and notified bodies to obtain licenses and CE markings. Ideally you will have US FDA exp. especially with 510(k) submissions.
This is an exceptional opportunity to work at the cutting edge of devices technology and gain valuable experience in a start up environment in an exceptional central London location.