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Human Factors Regulatory Specialist
2 months ago
Sagentia Innovation is a leading provider of independent advisory and product development services focused on science and technology initiatives. Our expertise spans multiple sectors, including medical, industrial, chemicals, and energy, food and beverage, and consumer goods.
The Opportunity
We are seeking a Human Factors Regulatory Consultant to join our 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 ensure compliance with regulatory requirements.
- Develop and implement Human Factors/Usability Engineering Files and use-related risk documentation.
- Provide expert advice on Human Factors and regulatory compliance to clients.
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
- Bespoke training and mentoring to support career development.
- Opportunities for business development expertise and pre-sales input.
- Competitive salary and benefits package.
About Sagentia Innovation
We are a world-class team of product developers and R&D strategists dedicated to delivering innovative solutions to our clients. Our expertise spans multiple sectors, and we are committed to providing exceptional service and support to our clients.
