Overview

Oracle Health is transforming its development and regulatory processes to meet heightened FDA, MDR, and ISO 14155 standards while addressing patient safety and compliance needs. As a clinical leader, you will provide organization-wide strategic oversight, ensuring product teams integrate clinical context, manage risks, and maintain compliance across legacy and new portfolios. This role drives modernization of clinical risk management and regulatory practices through AI-powered improvements.

Responsibilities

• Provide clinical leadership and strategic oversight for patient safety and compliance across Oracle Health's product portfolio.
• Guide product development teams in integrating clinical context and managing patient safety risks throughout the lifecycle.
• Ensure adherence to FDA, MDR, ISO 14155, and other regulatory standards for all products.
• Modernize clinical risk management processes in partnership with AI-driven tools and initiatives.
• Collaborate with cross-functional teams to develop and implement robust compliance frameworks.
• Lead efforts in product certification, audits, and regulatory submissions.
• Monitor and report on patient safety metrics, adverse events, and compliance status organization-wide.
• Advise executive leadership on clinical and regulatory strategies to support business growth.

Qualifications

• MD or DO degree with active medical license and board certification.
• 10+ years of experience in patient safety, clinical risk management, or regulatory affairs in healthcare technology.
• Deep expertise in FDA, MDR, ISO 14155, and global medical device regulations.
• Proven track record leading compliance programs in SaaS or health tech environments.
• Strong understanding of AI/ML applications in healthcare and associated regulatory considerations.
• Excellent communication skills with ability to influence cross-functional stakeholders.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance.
• 401(k) matching and employee stock purchase plan.
• Flexible remote work options across the United States.
• Professional development stipend and leadership training programs.