AI Regulatory Engineer for Healthcare AI Software
GE HealthCare
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Descrizione del lavoro
GE HealthCare in Norway is seeking an AI Regulatory Engineer to support the development and release of AI-enabled healthcare software. You will work with data scientists, software developers, data engineers, quality, clinical, and product stakeholders to align regulatory expectations with technical delivery.
The role involves translating regulatory requirements into actionable tasks, guiding risk management, design controls, and change management across the software lifecycle while contributing
Competenze
- Experience with regulatory affairs for medical devices and digital health.
- Familiarity with AI/ML development and regulatory expectations.
- Understanding of risk management and software lifecycle processes.
- Ability to communicate clearly with technical teams.
- Experience in regulated product development environments.
Mansioni
- Provide regulatory guidance from concept through product release and post-market activities.
- Translate regulatory expectations into practical requirements for AI, software, data, and model development.
- Support regulatory strategy, risk assessments, change assessments, and release readiness.
- Review and contribute to technical documentation including risk management and data governance.
- Assist with regulatory submissions, audits, and product documentation maintenance.
- Help teams address model limitations, bias, robustness, explainability, monitoring, and version control.
Conoscenze
Descrizione del lavoro
GE HealthCare in Norway is seeking an AI Regulatory Engineer to support the development and release of AI-enabled healthcare software. You will work with data scientists, software developers, data engineers, quality, clinical, and product stakeholders to align regulatory expectations with technical delivery.
The role involves translating regulatory requirements into actionable tasks, guiding risk management, design controls, and change management across the software lifecycle while contributing
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