Senior AI RAQA Specialist

AI Regulatory Affairs and Quality Assurance (RAQA) Specialists 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 Specialists will partner with innovators across Mayo Clinic to develop strategies, provide guidance, and demonstrate compliance with regulations and standards. RAQA Specialists may engage with external organization (e.g., FDA), as needed.

As a Senior RAQA Specialist 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 RAQA position can 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 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 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).

• Serve as a subject matter expert in regulatory, quality, and policy considerations affecting AI-enabled technologies and governance decisions.  
• Evaluate emerging laws, regulations, standards, and health policy developments and translate relevant changes into actionable recommendations.  
• Partner with policy and review functions to improve consistency, defensibility, and risk-based application of governance requirements across the product portfolio.   
• 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.
   

Qualifications

• A bachelor’s degree in engineering, computer science, health science, or a related analytical/quantitative field with a minimum of 5 years of experience or master’s degree in a related field with a minimum of 3 years of experience.
• 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.
• Familiarity with regulatory standards and compliance frameworks, with the ability to adapt these to different project environments effectively.
• 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.
• Advanced knowledge of healthcare regulation, quality systems, or AI governance; Experience developing policy, regulatory strategy, risk management, or quality programs