Head of Quality and Regulation in Software

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Head of Quality and Regulation in Software

Role: Head of Quality and Regulation in Software

Location: Soho, London + Remote working

Salary: £70,000 – £85,000

A business who are leaders in handheld medical diagnostic devices based in Soho are looking for a Head of QARA to take responsibility for the Company’s Quality Management System as well as helping to support product regulatory submissions. You will be responsible for the on-going maintenance of the Quality Management System as well as the on- going interpretation of regulation, guidance, and quality systems standards in order to drive forward improvement projects throughout the business.

Reporting into the Chief Regulatory and Compliance Officer, you will be detail-oriented, a people person and will possess a strong knowledge of medical device quality assurance systems. You will be passionate about putting patient safety first and playing your part in creating a more effective and efficient business. This is a hybrid role, that involves both remote working and occasional visits to the office, with the frequency to be agreed with your line manager.

The business has decided they are more than happy to train and develop the right person as long as they have a fair background in Software and a Regulatory understanding and way of working. The company is more than happy to train and develop the right individual, so long as there is a deep interest in this line of work.

Responsibilities

  • Accountable for the maintenance of core quality management system processes
  • Communication of quality system status to senior management team
  • Lead internal and external audits, checking conformity of working practise to quality system procedures
  • Analyse and communicate new or changing regulatory requirements to the business
  • Analyse quality system metrics and communicate conclusions to relevant stakeholders within the business
  • Provide training and support to the wider company on systems
  • Maintain periodic company regulatory registrations
  • Knowledge of quality assurance terminology, methods and common tools
  • Previous experience with management of Quality Management Systems
  • Experience in handling and coordinating responses to FDA and ISO inspections
  • Ability to work in a high paced start-up environment

The company is more than happy to train and develop the correct individual, there would be an expectation of a software background in a regulated environment, but even this is perhaps flexible for the right person. If you have the capability to evaluate situations, identify options and propose effective solutions with speed and efficiency this could well be the opportunity for you.

For more information on this unique role contact Andrew Knight at KO2 Recruitment today.

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