Senior AI RAQA Specialist

Why Mayo Clinic

Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans– to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic.

• Medical:
  
  Multiple plan options.
• Dental:
  
  Delta Dental or reimbursement account for flexible coverage.
• Vision:
  
  Affordable plan with national network.
• Pre-Tax Savings:
  
  HSA and FSAs for eligible expenses.
• Retirement:
  Competitive retirement package to secure your future.

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…