Human Factors Regulatory Specialist

4 weeks ago

Epsom, Surrey, United Kingdom Sagentia Full time

About the Opportunity

Sagentia Innovation is seeking a Human Factors Regulatory Consultant to support our growing Human Factors compliance offering within our Medical Sector. As a key member of our team, you will work closely with our Head of Human Factors to develop and implement Human Factors/Usability Engineering Files and use-related risk documentation, ensuring best practice and consulting directly with clients on key Human Factors projects.

Key Responsibilities

  • Collaborate with multidisciplinary medical device development teams in Sagentia Innovation and client project teams to ensure compliance with FDA human factors guidelines, MDR, IEC:62366, and HE 75 regulatory requirements.
  • Develop and implement use specifications, user interface specifications, and user interface evaluation plans, workflow assessment, and task analysis.
  • Document hazards and risks, including uFMEA/UERAs, and ensure traceability.
  • Support quality management in a project-based organization and have knowledge of ISO 13485, FDA QSR, and Medical Device Directive (MDD)/Medical Device Regulations (MDR).
  • Collaborate with our advisory team to deliver strategic visions and roadmaps requiring a human-centered approach.

Requirements

  • 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.
  • Experience in medical device project quality management in a project-based organization.
  • Degree-level qualification in a relevant engineering, design, or science discipline.
  • Knowledge of ISO 13485, FDA QSR, and Medical Device Directive (MDD)/Medical Device Regulations (MDR) to support additional quality engineering functions.

What We Offer

  • Bespoke training and mentoring to allow you to thrive within our environment and fully realize your personal goals and potential.
  • Opportunities for career development, including QMS continuous improvements, business development expertise, and strong interpersonal and communication skills.
  • A competitive salary and benefits package.

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