Quality Assurance & Regulatory Officer, £30-40k, Medical Devices

Recruiter
Meet Recruitment Ltd
Location
Cardiff (Caerdydd)
Salary
£30-40k
Posted
06 May 2017
Expires
11 May 2017
This medical device company are seeking a well organised, effective communicator to support the business in areas of Quality Assurance of Products and Services, meeting customers' needs and achieving business results whilst ensuring Regulatory Compliance and driving excellence. The site is one of many across the UK and is part of a wider group, for which it acts as the flap ship for as it has been well established for over a decade. This company are one of the UK's leading supplier of medical devices and pharmaceutical products to the primary and secondary care markets. QA/RA Officer, £30-40k, South Wales, Medical Devices Please contact Nathan Berkley on or email if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential. General Responsibilities: - To provide operational technical support for the Head of Regulatory Affairs regarding medical device regulatory affairs - To act as ISO Quality system representative to ensure compliance with ISO 13485 & ISO 9001 systems - Efficient administration and management of regulatory Technical files to maintain CE Marking - To develop and deliver strategy to meet the requirements of the new Medical Device and IVD Regulations - To provide a high level of customer service as first point of contact/key interface with externals on technical queries, complaints, recalls/FSCA, vigilance including post-marketing surveillance and quality issues for medical devices and pharmaceuticals. - To perform internal and external auditing as assigned in annual schedule including to ISO 9001, 13485 requirements. Skills Required: - Quality/Regulatory experience within a Medical Devices environment - Experience of technical file management - Experience of working in an ISO 9001:2008 environment and ISO 13485:2015 - Experience of auditing to ISO 9001 and/or ISO 13485 - Experience of regulatory body liaison e.g. the MHRA/HPRA/FDA - Proven ability to work as part of a multi-functional team. - A good understanding of commercial implications of role Please contact Nathan Berkley on or email if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential. Meet are good people who are great at recruitment. We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available. We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way. Find out more about us at: and -berkley-a25811139/ Key Words Medical Devices, IVD, Quality Assurance Officer, Senior Quality Associate, Quality Assurance, Quality Assurance Officer Jobs, Quality Assurance Specialist Jobs, Medical Device Jobs, QA Associate, QA/RA Associate, Quality Assurance Associate Jobs, Quality Assurance Associate, Quality Officer, Regulatory Officer, Regulatory Affairs Associate, Regulatory Affairs Specialist, Medical Device, Wales, South Wales, Cardiff, Swansea, Newport, Hereford