Note: The job is a remote job and is open to candidates in USA. Innolitics specializes in medical device software and supports companies in developing solutions and securing FDA clearance. The AI SaMD Regulatory and Engineer will support the development and regulatory clearance of AI-driven Software as a Medical Device by translating requirements into compliant designs and documentation, preparing regulatory submissions, and ensuring adherence to applicable standards. The role also contributes to risk management, technical files, audits, and continuous improvement of AI SaMD lifecycle processes.
Responsibilities
- Collaborating with software, AI/ML, and regulatory teams to translate clinical and business requirements into compliant technical designs and documentation
- Defining and implementing regulatory strategies, preparing submissions and supporting documentation for FDA and other regulatory bodies, and ensuring that AI models and software architectures meet applicable standards and guidance
- Contributing to risk management activities, maintaining design history and technical files, and participating in internal reviews, audits, and continuous improvement of processes related to AI SaMD development and lifecycle management
Skills
- Strong understanding of Regulatory Compliance and Regulatory Requirements applicable to AI-based SaMD
- Experience in Regulatory Affairs, including preparing and supporting regulatory submissions for medical devices
- Background in Quality Management and Quality Assurance within medical device or health software environments
- Knowledge of FDA, IEC, ISO, and other relevant standards and guidance for medical device software and AI/ML
- Practical experience with AI/ML engineering or software development for healthcare, including documentation and validation
- Ability to work effectively in a remote, cross-functional team and communicate clearly with technical and non-technical stakeholders
- Bachelor's or advanced degree in engineering, computer science, biomedical engineering, or a related discipline
- Experience with risk management, usability engineering, and cybersecurity considerations for medical software is beneficial
Benefits
- Full-time remote role
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