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.
Qualifications
· 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.
Key Responsibility
Cross-Organizational and Cross-Team Oversight
· Provide strategic clinical oversight across Oracle Health, partnering with product development, engineering, quality, and regulatory functions to align clinical best practices with product lifecycle activities.
· Ensure clinical compliance with FDA, MDR, and ISO 14155, acting as the central authority on interpreting and implementing these standards at all stages of software and device development. Bridge gaps in clinical expertise within product and engineering teams, providing training, mentorship, and continuous clinical risk evaluation for effective product design and certification. Support the transition from legacy Cerner software practices to Oracle’s modernized SDLC, ensuring alignment with global medical device development and design standards.
· Oversee clinical strategy, publications, and risk mitigation—ensuring the generation, dissemination, and application of clinical evidence and managing publications and communication of patient safety data.
Post-market/Product Surveillance Safety. Collaborate with, and support, Post-Market Surveillance Director and Quality and Patient Safety team to:
· Ensure appropriate assessment of product complaints requiring medical interpretation for assigned products
· Ensure appropriate medical assessment and determinations have been documented prior to submission of reports, including MDRs, to regulatory authorities.
· Provide medical input and assessment to regular and ad hoc product surveillance and safety reports for publication to regulatory authorities
· Provides medical support for reportability decisions and accurate coding for device adverse events and malfunctions
Risk Management & Regulatory support. Collaborate with, and support, the Quality, Regulatory and Patient Safety teams as follows:
· Contribute to the assessment of newly identified and potential risks for development of risk management plans and risk minimization activities.
· Contributes to the development and on-going review/revision of assigned product(s) Clinical Hazards Lists (CHL) and Application Failure Mode and Effects Analysis (aFMEAs)
· Reviews device risk management documents such as AE Matrix, Risk Management Plans, Risk Benefit Analysis, Design & process FMEAs, and Risk Management Reports
· Responsible for Health Product Hazard Assessments and Health Hazard Evaluations in the determination of Field Safety Corrective Actions (FSCA) and recalls, in collaboration with the Clinical Risk & Hazard Specialist who prepares these assessments.
· Contribute to writing safety responses to regulatory authorities
· Review literature to support submission of new device applications
· Engage with external regulatory bodies, audit teams, and certification agencies, representing Oracle Health in audit, submission, and compliance matters as needed.
Disclaimer:
Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements.
Range and benefit information provided in this posting are specific to the stated locations only
US: Hiring Range in USD from: $139,400 to $291,800 per annum. May be eligible for bonus, equity, and compensation deferral.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
- Medical, dental, and vision insurance, including expert medical opinion
- Short term disability and long term disability
- Life insurance and AD&D
- Supplemental life insurance (Employee/Spouse/Child)
- Health care and dependent care Flexible Spending Accounts
- Pre-tax commuter and parking benefits
- 401(k) Savings and Investment Plan with company match
- Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
- 11 paid holidays
- Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
- Paid parental leave
- Adoption assistance
- Employee Stock Purchase Plan
- Financial planning and group legal
- Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC5