Senior Regulatory Affairs Specialist - Medical Devices
Senior Regulatory Affairs Specialist - Medical Devices - Cambridgeshire
A growing medical devices company, based in Cambridgeshire, are currently in need of an experienced regulatory affairs specialist who will be able to assist with the management of regulatory affairs standards on a range of medical devices.
This is a unique role as you will work on more than one medical device, due to this you will ideally have worked for a few different medical devices companies (on different types of devices), worked for a company that produces a number of different types of devices or worked for a notified body where your product knowledge is utilised.
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.
It is expected that you would have a strong knowledge of regulatory standards within the UK, Europe and the US. So, in-depth knowledge of ISO 13485, CE Marking, FDA 510k and other standards will be essential.
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, bonus, benefits package and career progression. I expect this role to become more senior as the team grows.
For more information, please feel free to call Andrew Welsh, Director of Medical Devices recruitment and Scientific recruitment specialists Newton Colmore Consulting, on 0121 268 2240 or make an application and one of our team at Newton Colmore Consulting will contact you.
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.
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