Human Factors Regulatory Specialist
4 weeks ago
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, chemicals, and energy, to deliver innovative solutions to clients.
The Opportunity
We are seeking a Human Factors Regulatory Consultant to join our world-class team of product developers and R&D strategists. This role will involve supporting and developing 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 deliver Human Factors compliance solutions.
- Develop and maintain Human Factors/Usability Engineering Files and use-related risk documentation in accordance with FDA guidelines, MDR, IEC:62366, and HE 75 regulatory requirements.
- Conduct user interface evaluations, workflow assessments, and task analyses to ensure compliance with regulatory requirements.
- Provide expertise on ISO 13485, FDA QSR, and Medical Device Directive (MDD)/Medical Device Regulations (MDR) to support quality engineering functions.
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 quality engineering functions.
- Degree-level qualification in a relevant engineering, design, or science discipline.
What We Offer
We provide a competitive salary and benefits package, as well as opportunities for career development and growth within our organization. Our team is committed to delivering innovative solutions and exceptional client service.
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