Oracle Health Physician Executive, Patient Safety and ...

Job Description 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 portfoliou2014legacy and new. This role is essential in modernizing our clinical risk management and regulatory practices in partnership with AI-driven process improvements. Qualifications u00b7 Medical degree (MD, DO, or equivalent) required; board certification or clinical specialty training preferred. u00b7 Minimum 7 yearsu2019 experience in clinical leadership roles within medical device, digital health, or regulated healthcare software sectors. u00b7 Extensive experience in FDA, MDR, and ISO 14155 compliance, clinical risk management, and clinical evaluation for software and medical devices. u00b7 Proven track record leading cross-functional teams and serving as a principal clinical and compliance authority across an organization. u00b7 Experience with product hazard assessment, safety evaluation, and the regulatory submission process, especially for products newly classified under stricter EU medical device rules. u00b7 Knowledge of software development processes (including agile and/or AI-enabled methodologies) and their intersection with medical device regulatory requirements. u00b7 Outstanding collaboration, communication, and influence skills, with the ability to train and mentor diverse technical and clinical teams. u00b7 Experience working directly with regulatory authorities, notified bodies, and in external audit situations. Responsibilities Key Responsibility Cross-Organizational and Cross-Team Oversight u00b7 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. u00b7 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 Oracleu2019s modernized SDLC, ensuring alignment with global medical device development and design standards. u00b7 Oversee clinical strategy, publications, and risk mitigationu2014ensuring 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: u00b7 Ensure appropriate assessment of product complaints requiring medical interpretation for assigned products u00b7 Ensure appropriate medical assessment and determinations have been documented prior to submission of reports, including MDRs, to regulatory authorities. u00b7 Provide medical input and assessment to regular and ad hoc product surveillance and safety reports for publication to regulatory authorities u00b7 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: u00b7 Contribute to the assessment of newly identified and potential risks for development of risk management plans and risk minimization activities. u00b7 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) u00b7 Reviews device risk management documents such as AE Matrix, Risk Management Plans, Risk Benefit Analysis, Design & process FMEAs, and Risk Management Reports u00b7 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. u00b7 Contribute to writing safety responses to regulatory authorities u00b7 Review literature to support submission of new device applications u00b7 Engage with external regulatory bodies, audit teams, and certification agencies, representing Oracle Health in audit, submission, and compliance matters as needed. Disclaimer: Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates. Range and benefit information provided in this posting are specific to the stated locations only US: Hiring Range in USD from: $97,500 to $199,500 per annum. May be eligible for bonus and equity. 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 Oracleu2019s 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: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. 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. 9. 11 paid holidays 10. 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. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. 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 - IC4 About Us As a world leader in cloud solutions, Oracle uses tomorrowu2019s technology to tackle todayu2019s challenges. Weu2019ve partnered with industry-leaders in almost every sectoru2014and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. Thatu2019s why weu2019re committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. Weu2019re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling +1 888 404 2494 in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veteransu2019 status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

Created: 2025-12-19