Regulatory & QA Manager
Location: England England
Description: Zest Scientific is in need of Regulatory & QA Manager right now, this vacancy will be placed in England. For complete informations about this vacancy opportunity please give attention to these descriptions. Regulatory Affairs Manager Jobs Cambridge, QA Jobs East Anglia. Zest Scientific Recruitment has been instructed to identify an experienced Regulatory Affairs and Quality Assurance Manager with extensive exposure dealing with regulatory agencies associated with the regulation of Medical Devices in Europe and USA. The Regulatory & QA Manager will report directly to board level and will have significant input to strategic input for device design, process verification and validation activities.
Based at the Cambridge facility, the successful candidate will develop regulatory and quality strategie! s for new medical device products and developments of the exis! ting portfolio. My client operates in the global health informatics market and you will be required to ensure there is adherence and compliance to new developments in this field.
Creating, maintaining and supporting the regulatory and quality strategy; the Regulatory Manager will submit documentation for regulatory applications and act as general liaison with the relevant agencies. Ensuring that a quality system is established, implemented and maintained in accordance with the ISO 9001: 2000 and ISO 13485:2003 international standards. Additionally, you will drive internal compliance and provide further input into the development and maintenance of regulatory systems. The successful candidate will provide internal training, support Business Development teams and provide input to development teams. Input will relate to device design, process verification and validation activities.
It is essential that applicants can demonstrate previous experience in a Regul! atory & QA Management capacity in the Medical Device / Scientific arena. It is imperative that candidates have experience and knowledge of the relevant current requirements of major regulatory bodies (FDA, MHRA and EU) and are able to speed up the registration process through establishing excellent relationships with these bodies.
Salary package is negotiable (circa £65,000) plus additional benefits which include bonus, healthcare, share options. In order to discuss this opportunity in greater detail please contact Zest Scientific today on 0114 2381724 or forward an updated CV to matthew.morland@zestbusinessgroup.com
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Zest Scientific.
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This vacancy starts available on: Thu, 05 Dec 2013 ! 18:18:01 GMT