Human Factors Regulatory Specialist

7 days ago

Epsom, Surrey, 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 opportunity to support Sagentia Innovation's Human Factors compliance offering within our Medical Sector has arisen. We are seeking a Human Factors Regulatory Consultant to join our team of product developers and R&D strategists. This role will involve collaborating with our Head of Human Factors to develop HF/Usability Engineering Files and use-related risk documentation, ensuring best practice and consulting directly with clients on key HF projects.

We offer a multitude of exciting medical, diagnostic, and combination device projects for you to engage in HF activities, implementation, and project documentation. Our experienced applied science, engineering, and embedded software teams will help collaborate with you from insight generation to summative study and regulatory submission. Additionally, our advisory team delivers strategic visions and roadmaps requiring a human-centered approach.

To be successful in this role, you 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. You will create use specifications, user interface specifications, and user interface evaluation plans, workflow assessment, and task analysis. You will also have experience with hazard and risk-related documentation and traceability, including uFMEA/UERAs, and medical device project quality management in a project-based organization.

You will also have 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. You may also have experience in the recruitment, leading, and documentation of Voice of Customer, Formative, and Summative engineering studies, as well as previous background in a product design function.

We offer bespoke training and mentoring to allow you to thrive within our environment and fully realize your personal goals and potential. You will have the opportunity to develop QMS continuous improvements and be involved in internal projects relating to the implementation of new tools that may enhance our HF function. You will also have the opportunity to develop business development expertise by providing pre-sales input and assistance, interfacing directly with clients under the guidance of our business development team.

You will be offered a competitive salary and benefits package.

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