Senior Regulatory Engineer - IVD - London

Senior Regulatory Engineer - IVD - London A growing medical devices company in London are currently in need of an experienced regulatory engineer who will be able to assist with the management of regulatory affairs standards and quality management systems on their brand new IVD technology. This is a key role in the development of life-saving and life-improving medical devices. You will work closely with the quality assurance and design teams, within a ISO 13485 environment to ensure the success of the product and help steer future R&D pipeline. It is expected that you would have a strong knowledge of regulatory standards within the UK and Europe. So, in-depth knowledge of ISO 13485, CE Marking other standards will be essential. We are looking for people who have experience in the IVD market and who have had some experience with FDA submissions. Undertaking internal audits will be important in this role so hopefully you have experience of this in your current role. It is understood that you would most likely hold a degree within an engineering, design, medical or sciences background, however the industry exposure is more important than your education, for this role. You will be rewarded with a challenging role that you will never get bored with. As new medical devices are being developed all the time you will always be working on something new rather than managing pre-existing regulatory affairs documentation. Also, you will have an excellent starting salary, benefits package and career progression. For more information, make a confidential application now and a member of our team will be in touch with more details. Newton Colmore Consulting is a specialist recruitment company within the Medical Devices, Scientific Engineering, Scientific Software, Robotics, Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance and Field Service Engineering sectors. Medical Devices Regulatory Affairs Specialist, RA Specialist, Regulatory Affairs Manager, Quality Assurance, ISO 13485, CE Mark, CE Marking, FDA 510k, RA Consultant, RA Manager, Regulatory Affairs Consultant, IVD