Offer summary
Qualifications:
Bachelor's degree in engineering or related sciences, Four years of experience in healthcare products, Two years in developing SaMD and AI/ML models, Thorough understanding of software life cycle processes, Knowledge of related standards and AI regulations.
Key responsabilities:
- Conduct technical documentation reviews for SaMD and AI devices
- Collaborate with cross-functional teams to enhance quality
- Develop and present training internally or externally
- Project manage reviews for efficiency and compliance
- Maintain personal competency for reviewing technical files