Human Factors Regulatory Specialist
7 hours ago
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 Human Factors/Usability Engineering Files and use-related risk documentation, ensuring best practice and consulting directly with clients on key Human Factors projects.
- Support the development of use specifications, user interface specifications, and user interface evaluation plans, workflow assessment, and task analysis.
- Contribute to the creation of hazard and risk-related documentation and traceability, including uFMEA/UERAs.
- Assist in the implementation of quality management in a project-based organization.
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.
- Knowledge of ISO 13485, FDA QSR, and Medical Device Directive (MDD)/Medical Device Regulations (MDR) to support additional quality engineering functions.
- Degree-level qualification in a relevant engineering, design, or science discipline.
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 and business development expertise.
- A competitive salary and benefits package.
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