Quality Assurance & Regulatory Affairs (QARA) Manager

  • Location

    Hereford

  • Sector:

    Engineering, Professional & Interim, Manufacturing

  • Job type:

    Permanent

  • Salary:

    £40000 - £50000 per annum

  • Contact:

    Imogen Wilson

  • Contact email:

    iwilson@meridianbs.co.uk

  • Contact phone:

    0117 906 5808

  • Job ref:

    IW-21-1

  • Published:

    about 1 month ago

  • Expiry date:

    2021-03-16

  • Startdate:

    2021-03-02

  • Consultant:

    ConsultantDrop

Are you a Senior Quality and Regulatory professional with competence in ISO13485? We are recruiting for a Quality Assurance and Regulatory Affairs (QARA) Manager to join a leading medical devices manufacturer in Herefordshire. Salary up to £50k working Monday to Friday 37 hours per week (finishing at lunchtime on Fridays!)
 
As QARA Manager you will spend 80% of your time on Quality, and 20% on regulatory affairs. You will be managing a small team consisting of a Deputy QA Manager, and 2 QC Administrators. The purpose of the role is to ensure efficient management and continued improvement of the QMS which is a simple system yet mature and well established.
 
The continued certification of ISO13485 will be your responsibility along with providing strategic planning and framework to achieve commercial and quality goals. You will ensure any changes to the Medical Device Directive/ Regulation and Quality standards are disseminated throughout the company and appropriate risk analysis and actions are managed.  
 
It is essential you have at least 5 years experience working with ISO13485, within a senior Quality Management role. You will need experience of technical files, both Class 1 & 2 Medical Devices, and you will be Lead Auditor trained. Analytical and statistical techniques are required along with proficiency in Word and Excel.
 
This role would suit: SHEQ Manager, QHSE Manager, QA Manager, Group Quality Manager, Regulatory Affairs Manager, Quality and Risk Manager, Quality and Governance Manager