Overview

Oracle Health is building a specialized clinical product management team focused on medical device-aligned products, bridging clinical practice, product strategy, and regulatory engineering for patient safety, usability, and compliance. As Principal Clinical Consultant, you'll provide expert clinical insight into product design, usability, and risk management for next-generation EHR and AI-enabled medical device platforms. Collaborate with engineering, regulatory, and product teams to align development with ISO 14971, IEC 62366, and EU/US Clinical Evaluation standards.

Responsibilities

• Provide clinical expertise to guide product design, usability testing, and risk management processes for medical devices.
• Collaborate with engineering, regulatory, and product teams to ensure compliance with ISO 14971 and IEC 62366 standards.
• Conduct clinical evaluations and contribute to EU/US regulatory submissions and approvals.
• Identify and mitigate clinical risks in EHR and AI-enabled medical device platforms.
• Partner with stakeholders to define user requirements and validate product usability in clinical settings.
• Support product strategy by translating clinical needs into actionable development priorities.
• Review and approve clinical documentation, including use cases, hazard analyses, and validation reports.
• Mentor junior team members and represent clinical perspective in cross-functional leadership meetings.

Qualifications

• Advanced degree (MD, RN, or equivalent) with 10+ years of clinical experience in healthcare settings.
• 5+ years in medical device product management, regulatory affairs, or clinical consulting.
• Deep knowledge of ISO 14971, IEC 62366, EU MDR, and FDA clinical evaluation requirements.
• Proven experience with EHR systems, AI in healthcare, or medical device usability engineering.
• Strong collaboration skills across engineering, regulatory, and executive teams.
• Excellent communication and documentation skills for clinical and technical audiences.

Benefits

• Competitive salary and performance-based incentives.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and flexible work arrangements.
• Professional development stipend and certification support.
• Stock purchase plan and retirement savings match.