Oracle
Oracle Health Physician Executive, Patient Safety and Compliance
This role provides organization-wide clinical leadership and strategic oversight to ensure integration of clinical context, patient safety risk management, and compliance with FDA, MDR, and ISO 14155 standards across product development teams. It focuses on modernizing clinical risk management and regulatory practices in partnership with AI-driven process improvements.
Key Responsibilities
- • 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.
- • 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.
- • Provide medical support for reportability decisions and accurate coding for device adverse events and malfunctions.
- • Contribute to the assessment of newly identified and potential risks for development of risk management plans and risk minimization activities.
- • Contribute to the development and on-going review/revision of assigned product(s) Clinical Hazards Lists (CHL) and Application Failure Mode and Effects Analysis (aFMEAs).
- • Review 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.
Required
- • Medical degree (MD, DO, or equivalent) required
- • 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
Preferred
- • Board certification or clinical specialty training preferred
Benefits & Perks
- • 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 for salaried employees; Accrued Vacation for others with specified accrual rates
- • 11 paid holidays
- • Paid sick leave: 72 hours upon date of hire, refreshing each calendar year with carryover up to 112 hours
- • Paid parental leave
- • Adoption assistance
- • Employee Stock Purchase Plan
- • Financial planning and group legal
- • Voluntary benefits including auto, homeowner and pet insurance
Company Overview
Industry: Healthcare Technology
Company Size: 500-1,000 employees
Founded: 2015
Headquarters: San Francisco, CA
Company Links
Key Contacts
Contact information not available
About the Company
Leading healthcare technology company focused on improving patient outcomes through innovative digital solutions. We're transforming the way healthcare is delivered with cutting-edge technology and data-driven insights. Our platform serves over 10,000 healthcare professionals and has processed millions of patient interactions.
Recent News & Updates
Series B
Raised $50M Series B funding - Jan 2024
Award
Named "Best Healthcare Startup" by TechCrunch - Dec 2023
Growth
Expanded to 5 new states - Nov 2023
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 portfolio—legacy and new. This role is essential in modernizing our clinical risk management and regulatory practices in partnership with AI-driven process improvements.
Qualifications
Key Responsibility
Cross-Organizational and Cross-Team Oversight
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 - $199,500 per year. 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 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:
Career Level - IC4
About Us
As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That’s why we’re 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.
We’re 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 accommodation-request_mb@oracle.com 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 veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
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.
Qualifications
- Medical degree (MD, DO, or equivalent) required; board certification or clinical specialty training preferred.
- 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.
- 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
- 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 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 - $199,500 per year. 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 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
Career Level - IC4
About Us
As a world leader in cloud solutions, Oracle uses tomorrow’s technology to tackle today’s challenges. We’ve partnered with industry-leaders in almost every sector—and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That’s why we’re 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.
We’re 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 accommodation-request_mb@oracle.com 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 veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
Keep track of your job search
Save personal notes for each job to track your thoughts, application status, and follow-ups.
Try for freeUpload your resume
Sign up to upload your resume and get AI-powered customization for job applications.
Sign up freePractice your interview
Get AI-powered mock interviews tailored to this Oracle Health Physician Executive, Patient Safety and Compliance role. Upload your resume and practice with real-time voice feedback.
Sign up to practice