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Chemical Regulatory Affairs Specialist
2 months ago
Sagentia Innovation is seeking a skilled Chemical Regulatory Affairs Specialist to join our team. As a key member of our Medical Sector, you will play a crucial role in supporting our Human Factors compliance offering.
Key Responsibilities- Collaborate with multidisciplinary medical device development 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.
- Provide consulting services to clients on key Human Factors projects.
- Work closely with our Head of Human Factors to ensure best practice and effective project delivery.
- 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.
- Creation of use specifications, user interface specifications, and user interface evaluation plans, workflow assessment, and task analysis.
- Hazard and risk-related documentation and traceability, including uFMEA/UERAs.
- Experience of Medical device project quality management in a project-based organization.
- Knowledge of ISO 13485, FDA QSR, and Medical Device Directive (MDD)/Medical Device Regulations (MDR) to support additional quality engineering functions.
- Knowledge of generating technical publications, such as accompanying documentation and training materials.
- Bespoke training and mentoring to help you thrive within our environment and realize your personal goals and potential.
- Opportunities for career development and growth within our organization.
- A competitive salary and benefits package.
