Lead Regulatory Scientist - AI Medical Devices

Oracle Health Data Intelligence is hiring a Lead Regulatory Scientist to provide deep regulatory and scientific leadership for AI-enabled medical device solutions. This role sits within HDI’s Regulatory & Medical Device organization.
You will serve as a senior regulatory subject-matter expert who has lived both sides of the process — as a reviewer and as a submitter — bringing real-world regulatory judgment to HDI’s global medical device strategy cross our product portfolio.
This role is critical to shaping how Oracle delivers compliant, trusted, and scalable AI/ML-driven healthcare products across U.S. and European markets.

At Oracle Health Data Intelligence, our mission is to transform healthcare through trusted, intelligent technology —helping providers, life sciences organizations, and health systems deliver safer care, faster innovation, and better patient outcomes at global scale.
HDI is uniquely positioned at the intersection of:

• Clinical data
• AI and advanced analytics
• Cloud-scale infrastructure
• Regulatory-grade engineering

We are building the next generation of healthcare platforms that don’t just move fast — they move responsibly . Every solution we deliver is designed with:

• Patient safety first
• Scientific rigor
• Regulatory credibility
• Global compliance by design

For professionals in regulatory science , this is a rare opportunity to influence how AI-enabled medical technologies are governed, reviewed, and trusted — from inside one of the world’s most impactful healthcare technology organizations.
Your work directly enables:

• Responsible deployment of AI/ML in healthcare
• Faster access to innovative, compliant digital health solutions
• Global scale of trusted SaMD platforms
• A future where regulation accelerates — not blocks — innovation

Regulatory Review Leadership

• Lead regulatory strategy for AI/ML-enabled SaMD, digital health platforms, and medical imaging software.
• Bridge between Product Management and HCO
• Responsible for facilitating regulatory awareness across the organization
• Provide expert guidance on FDA pathways (510(k), De Novo, Breakthrough) and MDR/CE Mark processes.

Scientific & Regulatory Strategy

• Advise on risk-based approaches to AI/ML regulation, TPLC strategies, and post-market surveillance.

Submission Excellence

• Guide development and review of technical files, clinical evidence, and regulatory submissions.
• Ensure regulatory rigor is embedded early in product design.

European Regulatory Leadership (UK/EU role)

• Lead MDR and CE Mark strategy and partner with notified bodies and regional regulators.

Thought Leadership

• Contribute to regulatory science initiatives, policy discussions, and industry collaboration around AI in healthcare.

• 8+ years in medical device regulatory affairs or regulatory science.
• Direct experience as a reviewer, regulatory scientist, or senior regulatory affairs leader.
• Demonstrated experience reviewing AI/ML-enabled SaMD or digital health platforms.
• Deep understanding of FDA medical device regulation, European MDR, and CE Mark frameworks.

• Former experience at FDA, MHRA, Notified Bodies, or equivalent European regulatory agencies.
• Experience at companies such as Viz.ai, GE, Philips, Siemens, or advanced imaging organizations.
• Background in radiology, quantitative imaging, or clinical AI systems.

Career Level - IC4