Regulatory Affairs Officer

5 days ago


Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Quantumdx Group Full time

QuantuMDx Group is seeking a highly skilled Regulatory Affairs Officer to join their team.

The estimated salary for this position is £55,000 - £70,000 per year, depending on experience.

Job Overview

The Regulatory Affairs Officer will be responsible for ensuring that products meet regulatory requirements, including ISO 13485, ISO 14971, and IEC 62304 standards.

The successful candidate will work closely with the Quality team to develop policies and procedures to improve efficiency and quality, and promote the benefits of a quality system to all employees.

Main Responsibilities:

  • Manage individual projects and work packages as required
  • Maintain and administrate the electronic Quality Management System Q-Pulse
  • Work with purchasing staff to establish Quality requirements from external suppliers
  • Gather relevant data on QMS performance to facilitate statistical reporting

Requirements:

  • Industry experience working within a Quality Management System
  • Experience of working with IVD medical devices
  • Excellent analytical and problem-solving skills


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