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Quality and Regulatory Officer United Kingdom,  


Posted on : 06 April 2017

Project Description

results whilst ensuring Regulatory Compliance and driving excellence.   Main Duties/Responsibilities and Knowledge/Skills Requirements/Authorities   To provide operational technical support for the Head of Regulatory Affairs in particular regarding medical device regulatory affairs at both company and group level. To act as ISO Quality system representative to ensure compliance with ISO 13485 & ISO 9001 systems in conjunction with QEHS Department. 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 incl 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. Assistance with Group UK’s ISO 13485 quality management system including: monitoring, developing, reviewing and seeking approval for continuous improvements in ISO quality assurance policies and standard operating procedures Manage and optimise activities in line with the chosen strategy, regulatory requirements and agreed financial targets and resources. Manage and maintain good professional working relationships both internally and externally. [SO1] Ensuring that the processes needed for the quality management systems are established, implemented and maintained Reporting to management on the performance of the quality management system and any need for improvement. Ensuring the promotion and awareness of customer requirements throughout the organisation To maintain and improve on current business ethical standards (including DCC Vital Policy, Labour Standards Assurance Systems/SEDEX) for Group (UK). Maintain knowledge of applicable legislation, guidelines, ISO standards and current industry practice that impact Quality and Regulatory Affairs for medical devices and pharmaceutical distribution. Support sharing of best practices across DCC Vital companies including application of Lean techniques where appropriate Although the above is a description of the requirements of the role, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time.   The role demands a well-organised approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing. Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.   Experience and Key Skills   Regulatory experience in Medical Devices including 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 Lead Auditor qualification in quality assurance desirable Experience of regulatory body liaison e.g. the MHRA/HPRA/FDA Proven ability to work as part of a multi-functional team Highly effective problem solver, excellent communicator, both verbal and written Computer literate and clear & concise report writer Ability to produce results, prioritising objectives and scheduling work to make best use of time and resources A good understanding of commercial implications of role QMS software systems experience Ability to cope effectively with pressure and setbacks and maintain commitment in spite of opposition Proven ability and experience of working on own initiative, and to play a proactive role as part of the wide Quality and EHS team based in the group Flexibility to travel within the group to subsidiary sites if required  [SO1]Covered in bullet point above re: high level of customer service

Locations

South Wales

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