Oracle Health Physician Executive, Patient Safety and Compliance

Oracle

24d

About The Position

Oracle Health is transforming its development and regulatory processes to meet heightened FDA, MDR, and ISO 14155 standards and address ongoing patient safety, compliance, and product certification needs. As a clinical leader with patient safety and compliance expertise, you will provide organization-wide clinical leadership and strategic oversight, ensuring our product development teams integrate clinical context, manage patient safety risks, and maintain robust compliance across the entire portfolio—legacy and new. This role is essential in modernizing our clinical risk management and regulatory practices in partnership with AI-driven process improvements. Ideally, this role would be an excellent match for a practicing or recently practicing physicians who care about keeping populations safe at scale.

Requirements

Medical degree (MD, DO, or equivalent) required; board certification or clinical specialty training preferred.
Recent experience as a practicing physician
Minimum 7 years’ experience in clinical leadership roles within medical device, digital health, or regulated healthcare software sectors.
Extensive experience in FDA, MDR, and ISO 14155 compliance, clinical risk management, and clinical evaluation for software and medical devices.
Proven track record leading cross-functional teams and serving as a principal clinical and compliance authority across an organization.
Experience with product hazard assessment, safety evaluation, and the regulatory submission process, especially for products newly classified under stricter EU medical device rules.
Knowledge of software development processes (including agile and/or AI-enabled methodologies) and their intersection with medical device regulatory requirements.
Outstanding collaboration, communication, and influence skills, with the ability to train and mentor diverse technical and clinical teams.
Experience working directly with regulatory authorities, notified bodies, and in external audit situations.