Human Factors Regulatory Consultant

Location Cambridgeshire, England
Discipline: Technical & Engineering Recruitment
Job type: Permanent
Salary: ££45000 - £52000 per annum
Contact name: Jen Richardson

Contact email: jrichardson@theonegroup.co.uk
Job ref: BBBH39365_1630397037
Published: 22 days ago

This Cambridge based team are growing in all directions and their Human Factors department is no exception. To keep up with the increasing compliance associated with their medical sector, this role will give you the opportunity to collaborate with multi-disciplinary medtech development teams who are, quite simply, some of the best in the world!

Supporting the Head of Human Factors (HF), your day-to-day work will include developing HF/Usability Engineering Files and use-related risk documentation, whilst ensuring best practice and consulting directly with customers on key HF projects. We are looking for someone who will be the 'voice of the customer' and really be able to explore and communicate their needs. It is a customer facing role, so naturally, you'll be confident interacting with people.

What else is important?

  • Degree qualified in a relevant engineering, design or science discipline - perhaps even a Psychology background could fit!
  • You will bring with you some proven experience working in a HF function and be confident documenting outputs in accordance with FDA human factors guidelines, MDR, IEC:62366 and HE 75 regulatory requirements
  • Creation of use specifications, user interface specifications and user interface evaluation plans, workflow assessment and task analysis
  • Hazard and risk related documentation and traceability including uFMEA/UERAs
  • Experience of Medical device project quality management in a project-based organisation.
  • Knowledge of ISO 13485, FDA QSR and Medical Device Directive (MDD)/Medical Device Regulations (MDR) would be very helpful
  • Previous background in a product design function would also be a big plus!

Not only will you be working on some of the most incredible, life-changing products around, you will be supported by a world-class team of people who are going to be keen to support you with bespoke training and mentoring. They WANT you to develop. If you'd like to find out more, our dedicated consultant would be keen to talk to you!