Breakthrough

In this role, the employee leads the strategic evolution of the AIA governance framework by translating emerging regulatory requirements, organizational experience, and industry best practices into scalable governance policies and operating models. Serves as the authoritative resource for policy interpretation and governance precedent, providing consultation on complex or novel matters that require enterprise-level consistency and risk-based decision making. Represents the AIA program internally and externally through publications, presentations, professional societies, and stakeholder engagement activities that advance responsible AI governance practices. 

AI Regulatory Affairs and Quality Assurance (RAQA) staff at Mayo Clinic ensure compliance with applicable regulations for the design, development, deployment, and maintenance of AI-enabled digital health technologies (DHTs) intended to meet the needs of the patients. RAQA staff will partner with innovators across Mayo Clinic to develop strategies, provide guidance, and demonstrate compliance with regulations and standards. RAQA staff may engage with external organization (e.g., FDA), as needed.

As a Principal AI RAQA specializing in AI-enabled DHTs at Mayo Clinic, you will be at the forefront of working with teams to innovate AI-driven solutions that enhance patient care and clinic operations. In this pivotal role, you'll lead the creation of regulatory strategies, frameworks, systems, and/or processes, ensuring our digital health technology products meet the applicable requirements and/or best practices, including demonstration of safety and effectiveness in clinical settings, when applicable.

The day-to-day work involves collaborating with a multidisciplinary team, including clinicians, engineers, and external partners, to develop roadmaps for compliant deployment of DHTs across the Mayo Clinic Enterprise. This work encompasses the entire lifecycle of navigating regulations. You'll guide the application of regulations, standards, and best practices for pre- and post-deployment stages of AI-enabled DHTs. In partnership with colleagues in the Center for Digital Health, you will ensure compliance with the quality management system regulations (QMSR) and/or establish processes for continue improvement and maintenance of the QMSR.

This role is instrumental in providing consultative services to departments and divisions, offering insights into complex business problems. Your ability to communicate multifaceted strategies to key stakeholders will advance translational and regulatory science across the Mayo Clinic Enterprise.

This Principal AI RAQA position can be fulfilled by an individual with experiences monitoring, interpreting, and applying laws, regulations, and standards for AI-enabled DHTs. This individual should have experience in regulatory affairs with writing medical device status determinations, authoring US FDA submissions, and assessing post-market changes for impact.
This Principal AI RAQA position can also be fulfilled by an individual with experience establishing, maintaining, and improving a quality management system (QMS) for AI-enabled DHTs. This individual should have experience in quality assurance with writing standard operating procedures and templates for the QMS, conducting internal and external audits, and managing training requirements for applicable staff.

This Principal AI RAQA position can also be fulfilled by an individual with experience interpreting and applying requirements per the QMSR for AI-enabled DHTs. This individual should have experience in quality engineering subject to 21 CFR 820.30, having conducting activities such as risk management, design controls, and appropriate testing (e.g., verification and validation).

• Lead the strategic evolution of the AIA governance framework by translating emerging regulatory requirements, organizational experience, and industry best practices into scalable governance policies and operating models.  
• Serve as the authoritative resource for policy interpretation and governance precedent, providing consultation on complex or novel matters that require enterprise-level consistency and risk-based decision making.  
• Represent the AIA program internally and externally through publications, presentations, professional societies, and stakeholder engagement activities that advance responsible AI governance practices.   
• Lead the integration and standardization of software components to create AI-driven solutions that enhance patient care and clinic operations.
• Collaborate with clinicians, knowledge architects, and external partners to develop sophisticated AI and analytics solutions accessible to non-technical users.
• Oversee the engineering of systems crucial for developing and deploying AI solutions.
• Facilitate consistent and automated AI software solution development and releases through the design, testing, and maintenance of tools and associated CI/CD pipelines.
• Provide consultative services to departments and divisions, offering insights into complex business problems through advanced analytics.
• Lead the interpretation of data analysis to inform strategic decisions and communicate complex findings in easily understandable terms to bridge the gap between AI technologies and clinical applications. 
• Provide mentorship, guidance, and technical leadership to junior staff members. May have supervisory responsibilities. 

This vacancy is not eligible for sponsorship/ we will not sponsor or transfer visas for this position. Also, Mayo Clinic DOES NOT participate in the F-1 STEM OPT extension program.

• A bachelor’s degree in engineering, computer science, health science, or a related analytical/quantitative field with a minimum of 7 years of experience or master’s degree in a related field with a minimum of 5 years of experience.
• Extensive experience interpreting the FDA’s regulatory policies for digital health technologies, sitting on core teams as an RA/QA representative for new product development, and/or facilitating completion of documentation intended for FDA review (e.g., Q-Submissions, 510(k) submissions, PMAs, etc.)
• Experience reviewing and interpreting 21 CFR 820, applicable standards (e.g., ISO 13485, 14971, 62304, 62366), and evolving best practices (e.g., FDA’s Good Machine Learning Principles)
• Demonstrated leadership in managing complex projects, with a proven ability to navigate intricate project requirements and deliver successful outcomes.
• Proficiency in fostering collaboration across diverse teams and effectively communicating complex technical concepts to non-technical stakeholders.
• Demonstrated application of problem-solving methodologies, continuous improvement methods, and analytical tools (e.g., machine learning, statistical packages).
• Demonstrated initiative in administration, education, software development, and technical reporting. A commitment to mentoring and training less-experienced team members, coupled with strong interpersonal, communication, and time management skills.

Preferred Qualifications

• A master’s degree in a related field (engineering, computer science, health science, or a related analytical/quantitative field).
• Advanced AI, machine learning, and data analytics knowledge applicable to digital health technologies.
• Exceptionally skilled with monitoring and interpreting new and changing new and changing regulations and standards.
• Experience interpreting, influencing, commenting on, etc. regulatory standards and compliance frameworks for AI-enabled digital health technologies.
• Demonstrated risk assessment and management capability, establishing robust testing strategies for technology solutions.
• Proven success in leading multidisciplinary teams and fostering collaboration to drive project success and innovation.
• Strong ability to articulate complex technical concepts to diverse audiences, facilitating clear understanding and engagement from technical and non-technical stakeholders. 
• Experience leading policy, regulatory, quality, compliance, or governance programs in regulated environments .
• Record of publications, presentations, professional committee participation, or standards-development activities