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Human Factors Regulatory Specialist

1 month ago

Cambridge, Cambridgeshire, United Kingdom Sagentia Full time

Sagentia Innovation is a leading provider of independent advisory and product development services focused on science and technology initiatives. Our team of experts works across various sectors, including medical, industrial, and consumer goods, to deliver innovative solutions to our clients.

The Human Factors Regulatory Consultant role is a key position within our Medical Sector, supporting the development of Human Factors/Usability Engineering Files and use-related risk documentation. This role requires collaboration with multidisciplinary medical device development teams and client project teams to ensure best practice and regulatory compliance.

We offer a range of exciting medical, diagnostic, and combination device projects for the successful candidate to engage in Human Factors activities, implementation, and project documentation. Our team includes experienced applied science, engineering, and embedded software experts who can collaborate on insight generation, summative studies, and regulatory submissions.

The ideal candidate will have proven experience working in a Human Factors function, guiding pragmatic activities, and documenting outputs in accordance with FDA human factors guidelines, MDR, IEC:62366, and HE 75 regulatory requirements. This includes creation of use specifications, user interface specifications, and user interface evaluation plans, workflow assessment, and task analysis.

The successful candidate will also have experience of Medical device project quality management in a project-based organization, 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 is required.

We offer bespoke training and mentoring to allow the successful candidate to thrive within our environment and fully realize their personal goals and potential. The role offers opportunities for QMS continuous improvements, business development expertise, and strong interpersonal and communication skills.

We offer a competitive salary and benefits package to the successful candidate.