Our Client is one of the world's leading designers, manufacturers and providers of blood flow imaging and monitoring products for the Clinical and Research medical device market. They are guided by an ethos of technical excellence, stringent quality control and total customer service. An opportunity has now arisen for a Quality / Regulatory Affairs Officer to join our team. This role would suit a quality assurance / regulatory affairs professional from a medical device/instrument manufacturer background. As a Quality Assurance / Regulatory Affairs you'll be responsible for fostering, driving forward and embedding the organisation’s Quality Management Systems (QMS) in line with medical device quality (ISO 13485) and regulatory (MDD 93/42 EEC & Directive 2007/47 EC) standards in terms of product design control, production, training of staff and customer support. Within these areas, you will also be required to initiate, facilitate and support process improvement; ensuring CE marked products meet EEA standards and directives. Your other duties will include: - preparing regulatory submissions for global product registrations/approvals; for example FDA 510K submissions - communicating with outside agencies/regulatory bodies - updating and reviewing IFUs, packaging, labelling and marketing literature - planning and implementing health and safety issues for the company To be considered for the role of Quality Assurance / Regulatory Affairs Officer, you must ideally have quality assurance and regulatory affairs experience gained within a medical device or instrument manufacture environment and a good level of IT literacy, including MS Word and Excel. Additionally, you will have good written and verbal communication skills. A meticulous approach to our work and the ability to be a team player are important attributes for the post.

Posted in East Devon | Manufacturing

Submitted by devonrec on Tue, 2011-09-20 05:00.