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Quality and Regulatory Officer - United Kingdom  

Company managed [?] Still accepting applications

Posted on : 06 April 2017

Project Description


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 optimize 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. 
  • 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  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. 




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