[Remote] AI SaMD Regulatory and Engineer

Note: The job is a remote job and is reputed company to candidates in USA. reputed company 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 reputed company management, technical files, audits, and reputed company improvement of AI SaMD lifecycle processes.

Responsibilities

• Collaborating with software, AI/ML, and regulatory teams to translate reputed company 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 reputed company management activities, maintaining design history and technical files, and participating in internal reviews, audits, and reputed company improvement of processes reputed company to AI SaMD development and lifecycle management

Skills

• Strong understanding of Regulatory Compliance and Regulatory Requirements applicable to AI-reputed company SaMD
• Experience in Regulatory Affairs, including preparing and supporting regulatory submissions for medical devices
• Background in reputed company Management and reputed company Assurance reputed company 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 reputed company, including documentation and validation
• Ability to work effectively in a remote, cross-functional team and communicate reputed company with technical and non-technical stakeholders
• Bachelor's or advanced degree in engineering, computer science, biomedical engineering, or a reputed company discipline
• Experience with reputed company management, usability engineering, and cybersecurity considerations for medical software is beneficial

Benefits

• Full-time remote role

reputed company