Human Factors Regulatory Consultant

Human Factors Regulatory Consultant
£40k-£55k (dep on exp)

An excellent career opportunity has opened for an experienced technically skilled Human Factors Regulatory Consultant to join a highly regarded Technology Development Consultancy in Cambridgeshire. The Human Factors Regulatory Consultant will play a pivotal role within the medical sector – joining their world-class team of product developers and R&D strategists.

You will have the opportunity to support and develop HF/Useability Engineering files and be consulting directly with clients on key Human Factors projects. This position has a large amount of collaboration with multidisciplinary medical device development teams in the Innovation department, not to mention collaborating with clients’ project teams also.

The Human Factors Regulatory Consultant will suit someone who has a background in mechanical engineering who has moved into Human Factors related areas, within a medical device development area – thus having knowledge and experience of regulatory compliance would be a distinct advantage.

Ideally, the Human Factors Regulatory Consultant, will have the following:
• Proven experience working in a HF function guiding pragmatic activities and documenting outputs in accordance with FDA human factors guidelines, MDR, IEC: 62366 and HE 75 regulatory requirements. These include:
• 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) to support additional quality engineering functions.
• A degree level qualification in a relevant engineering, design or science discipline.

Job Details

  • Job Ref: 12208
  • Salary: £40000 - £55000
  • Consultant Name: Darren Holmes
  •   Cambridgeshire
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