Lead Quality and Compliance Manager for AI-Enabled ...

Job Description Are you passionate about enhancing healthcare with innovative technologies? Oracle Health Data Intelligence is looking for a Quality Manager to spearhead and evolve our quality systems and regulatory compliance for AI-enabled Software as a Medical Device (SaMD) and digital health solutions. This pivotal role is part of HDI's Regulatory & Medical Device organization. As a quality leader, you'll ensure HDI maintains exceptional quality systems and readiness for audits while aligning with regulatory standards as we expand into U.S. and European markets. This opportunity is perfect for individuals who excel in regulated environments, understand the essence of a robust quality system, and possess both strategic insight and hands-on capability. At Oracle Health Data Intelligence, our mission is to transform healthcare with trusted, intelligent technology. We empower healthcare providers, life sciences organizations, and health systems to deliver safer care, accelerate innovation, and achieve better patient outcomes on a global scale. HDI is strategically positioned at the convergence of: Clinical data AI and advanced analytics Cloud infrastructure Regulatory-grade engineering We are creating the next generation of healthcare platforms that prioritize responsible progress. Every solution we provide is designed with: Patient safety as the highest priority Scientific rigor Regulatory credibility Built-in global compliance For quality and regulatory science professionals, this is a unique chance to influence how AI-driven medical technologies are governed, assessed, and trusted from within one of the most renowned healthcare technology organizations. Your contributions will enable: Safe integration of AI/ML in clinical decision-making Accelerated access to crucial digital health solutions Global expansion of compliant, scalable SaMD platforms A future where innovation and regulation harmonize, rather than conflict Responsibilities Leadership in Quality Systems Lead the evolution of HDI's Quality Management System (QMS) in accordance with: FDA QSR / 21 CFR Part 820 ISO 13485 ISO 14971 IEC 62304 SOC2 and InfoSec frameworks Audit and Inspection Readiness Prepare for medical device inspections, Notified Body audits, and SOC2/ISO reviews. Act as a primary quality advisor during regulatory assessments. Regulatory and Product Collaboration Work alongside Regulatory Scientists, Engineering, Product, and Security to ensure submission and technical documentation achieves approval standards. Design Controls and Risk Management Lead the implementation of design controls, risk management (FMEA, hazard analysis), V&V, and DHF preparation. Quality as a Strategic Ally Integrate quality early in product development and influence decisions with strong regulatory insight. Required Qualifications 8+ years of experience in medical device, SaMD, or regulated healthcare environments. Proven experience in QMS implementation and audit readiness. Deep understanding of FDA regulations, ISO 13485, and SOC2 compliance. Experience collaborating with regulatory and product teams on submissions. Ability to think and act both strategically and tactically. Preferred Experience Background in digital health, AI/ML medical software, or imaging technologies. Experience with CE Mark preparation and Notified Body audits. Previous experience at organizations such as Enzyme, Cortechs.ai, HealthLytix, Edwards Lifesciences, or ResMed. Career Level - IC4 Disclaimer: Certain US customer or client-facing roles may require compliance with applicable health mandates. Range and benefit information provided in this posting are specific to the stated locations only. US: Hiring Range in USD from: $90,100 to $199,500 per annum. Eligibility for bonus and equity may apply. Oracle maintains broad salary ranges for its roles to reflect variations in knowledge, skills, experience, market conditions, and locations, as well as the unique products, industries, and business lines of Oracle. Candidates are typically placed within the range based on these factors and internal peer equity. Oracle US offers a comprehensive benefits package that includes: Medical, dental, and vision insurance, including access to expert medical advice Short-term and long-term disability insurance Life insurance and AD&D coverage Supplemental life insurance options Flexible Spending Accounts for healthcare and dependent care Pre-tax commuting and parking benefits 401(k) savings plan with company match Flexible vacation policy and accrued vacation time 11 paid holidays annually Paid sick leave with carryover provisions Paid parental leave Adoption assistance Employee Stock Purchase Plan Financial planning and group legal services Voluntary benefits including auto, homeowner, and pet insurance This role will accept applications for at least three calendar days from the posting date or as long as the job remains open. About Us Oracle uniquely combines data, infrastructure, applications, and expertise to drive innovation and provide life-saving care. With integrated AI across our products, we support clients in creating a better future for everyone. Explore your potential at a company leading the charge in AI and cloud solutions that affect billions of lives. True innovation arises when everyone is empowered to contribute. That’s why we are committed to developing a workforce that fosters inclusivity, with competitive benefits and flexible options that support our employees. We also promote community engagement through our volunteer initiatives. We are dedicated to including individuals with disabilities throughout the employment process. If you require any accessibility assistance or accommodations, please reach out via email. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will be considered for employment without discrimination on any protected characteristic.

Created: 2026-03-10