Senior AI QA Specialist - CDH - Remote

$122,387 - $177,445/Yr

Mayo Clinic - Rochester, MN

Full-time - Senior

Remote - Rochester, MN

Hospitals

About the position

The Senior AI Quality Assurance (QA) Specialist at Mayo Clinic plays a crucial role in ensuring compliance with regulations for AI-enabled digital health technologies (DHTs). This position involves collaborating with multidisciplinary teams to develop regulatory strategies and frameworks that enhance patient care and clinic operations. The specialist will lead the creation of processes to ensure that digital health technology products meet applicable requirements and best practices, guiding the application of regulations throughout the product lifecycle.

Responsibilities

• Ensure compliance with applicable regulations for AI-enabled digital health technologies (DHTs).
• Partner with innovators to develop strategies and demonstrate compliance with regulations and standards.
• Engage with external organizations, such as the FDA, as needed.
• Lead the creation of regulatory strategies, frameworks, systems, and processes for AI-enabled DHTs.
• Collaborate with clinicians, engineers, and external partners to develop roadmaps for compliant deployment of DHTs.
• Guide the application of regulations and standards for pre- and post-deployment stages of AI-enabled DHTs.
• Ensure compliance with quality management system regulations and establish processes for continuous improvement.
• Provide consultative services to departments and divisions, offering insights into complex business problems.
• Communicate multifaceted strategies to key stakeholders to advance regulatory science.

Requirements

• Bachelor's degree in engineering, computer science, health science, or a related analytical/quantitative field with a minimum of 5 years of experience, or a master's degree in a related field with a minimum of 3 years of experience.
• Experience interpreting FDA regulatory policies for digital health technologies and facilitating documentation for FDA review.
• Experience reviewing and interpreting 21 CFR 820 and applicable standards such as ISO 13485, 14971, 62304, and 62366.
• Demonstrated leadership in managing complex projects and navigating intricate project requirements.
• Proficiency in fostering collaboration across diverse teams and communicating complex technical concepts to non-technical stakeholders.
• Demonstrated application of problem-solving methodologies and analytical tools.

Nice-to-haves

• Master's degree in a related field (engineering, computer science, health science, or a related analytical/quantitative field).
• Advanced knowledge of AI, machine learning, and data analytics applicable to digital health technologies.
• Familiarity with regulatory standards and compliance frameworks.
• Demonstrated risk assessment and management capability.
• Proven success in leading multidisciplinary teams and fostering collaboration.

Benefits

• 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.