Human Factors Regulatory Specialist
2 months ago
About Sagentia Innovation
Sagentia Innovation is a leading provider of independent advisory and product development services focused on science and technology initiatives. We work across various sectors, including medical, industrial, chemicals, and energy, food and beverage, and consumer goods, serving a broad range of companies from leading brands to start-up disruptors.
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 ensure effective Human Factors implementation and project documentation.
- Develop and maintain Human Factors/Usability Engineering Files and use-related risk documentation in accordance with FDA human factors guidelines, MDR, IEC:62366, and HE 75 regulatory requirements.
- Conduct hazard and risk-related documentation and traceability, including uFMEA/UERAs.
- Support Medical device project quality management in a project-based organization.
- Ensure compliance with ISO 13485, FDA QSR, and Medical Device Directive (MDD)/Medical Device Regulations (MDR) requirements.
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.
- A Degree-level qualification in a relevant engineering, design, or science discipline.
Desirable Skills
- Experience in the recruitment, leading, and documentation of Voice of Customer, Formative, and Summative engineering studies.
- Previous background in a product design function.
- Knowledge of generating technical publications, such as accompanying documentation and training materials.
- Worked in a client-facing consulting environment.
Career Development
We offer bespoke training and mentoring to allow you to thrive within our environment and fully realize your personal goals and potential. You will have the opportunity to develop:
- QMS continuous improvements and be involved in internal projects relating to the implementation of new tools that may enhance our Human Factors function.
- Business development expertise by providing pre-sales input and assistance, interfacing directly with clients under the guidance of our business development team.
- Strong interpersonal and communication skills, to gain the confidence and capability required in a client-facing role.
Benefits
You will be offered a competitive salary and benefits package.
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