Quality and Regulatory Officer ISO 13485

Focus Resourcing
06 May 2017
05 Jun 2017
Contract Type
Full Time

Our client is looking for a Quality and Regulatory Officer to join their team. The role will report into the Head of Regulatory Affairs.


  • To act as ISO Quality system representative to ensure compliance with ISO 13485 and ISO 9001 systems in conjunction with QEHS Department
  • 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
  • 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

Essential Skills:

  • 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
  • QMS software systems experience

Company offer an excellent working environment, good benefit package and career progression.