Senior Human Factors Regulatory Consultant

1 month ago


Epsom, Surrey, United Kingdom SAGENTIA Full time
Job Opportunity

Sagentia Innovation, a leading provider of independent advisory and product development services, is seeking an experienced Senior Human Factors Regulatory Consultant to join our Medical Sector team.

About the Role

This exciting opportunity allows you to support our growing Human Factors compliance offering by providing expert guidance on HF/Usability Engineering Files and use-related risk documentation. You will collaborate with multidisciplinary medical device development teams and clients to ensure best practice in human factors projects.

Key Responsibilities
  • Develop and maintain high-quality HF/Usability Engineering Files and use-related risk documentation
  • Collaborate with clients and internal teams to provide expert guidance on human factors projects
  • Support the implementation of new tools and processes to enhance our Human Factors function
Requirements

To succeed in this role, you will need:

  • 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
  • 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 organization
  • Knowledge of ISO 13485, FDA QSR, and Medical Device Directive (MDD)/Medical Device Regulations (MDR) to support additional quality engineering functions
  • Knowledge of generating technical publications, such as accompanying documentation and training materials
Career Development and Benefits

We offer a competitive salary ($80,000 - $110,000 per annum), a comprehensive benefits package, and opportunities for career growth and professional development. Our bespoke training and mentoring programs will enable you to thrive within our environment and realize your personal goals and potential.

About Sagentia Innovation

We help transform possibilities into successful products by combining expertise in science and technology with our love of invention and problem-solving.



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