Regulatory & Risk Manager - Medical Equipment

Kirkham Young Ltd
31 Jul 2017
16 Aug 2017
Contract Type
Full Time
Regulatory & Risk Manager - Capital Medical Equipment
This new UK based company is poised to change the face of haemodialysis and so revolutionise care for patients with renal disease. Developed by a team of highly experienced scientists and engineers, with clinical guidance from several leading renal specialists in the UK, USA and Germany this new technology offers the chance for patients to self-care and dialyse at home.
This new role will be responsible for developing a regulatory strategy and to maintain regulatory compliance for the company's novel product offering. This will include demonstrating regulatory compliance and driving the vigilance processes eg post marketing surveillance, adverse events, competitor information, changes in regulations etc across Europe, the USA and other markets. You will also provide advice and guidance to risk teams on various projects and design/ development teams.
To apply you will need a comprehensive understanding of relevant medical device regulatory standards and their implementation i.e. Medical Device Directive (93/42EEC), ISO 13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304, 21 CFR 820,21CFR 807, 21 CFR 11 and have experience working with complex medical devices needing broad development teams specialising in mechanical engineering, software, electronics, system integration, pneumatics, fluid mechanics, etc. Trained in the application of IS014971, you will have experience of working with risk management, regulatory requirements, document management and issue management systems.
This is an exciting position in a new company so there will be much scope for an enthusiastic Risk and Regulatory Manager to make their mark. It's a fabulous opportunity to be in at the start of this exciting new launch and for an individual interested in long term career development in medical device risk and regulatory management would be an ideal role.

Please note that the hiring organisation follows safe and transparent recruitment practices and all appointments may be subject to reference and DBS checks.
West Midlands, Warwickshire, warwick, birmingham, worcester, coventry, stratford upon avon, redditch, evesham, worcester, bromsgrove, leamington spa