Senior SaMD Quality Engineer - AI/ML & Regulatory Leader
Heartflow
Heartflow in San Francisco is advancing AI-driven cardiac care with SaMD. As Principal Device Quality Engineer, you will be the global SME for software quality and design excellence, aligning Agile development with medical device regulations across the SDLC. Lead design control, risk management, V&V oversight, and regulatory submissions with FDA, PMDA, and EU-MDR; mentor R&D, Product, and Program teams; drive compliance at speed in a regulated environment. #J-18808-Ljbffr Heartflow
- Hinge Health is seeking a Senior Regulatory Affairs Program Manager to lead regulatory strategy for our AI/ML SaMD portfolio. You will author submissions and collaborate with Product, Clinical, and Engineering teams to interpret evolving FDA guidance for AI/ML and ensure...Regulatory
- ...Health in the United States seeks a Regulatory Compliance Lead to develop and maintain... ...across consumer, research, and SaMD products, including AI/ML-enabled applications, with an eye toward... ...US expansion. You will partner with engineering and product teams to operationalize...Regulatory
- Verily Health is seeking a Quality Systems and Compliance Lead to... ...quality initiatives with regulatory impact. You will design, implement... ..., and coordinate with engineering, product, and operations to... ...quality into development for AI/ML and SaMD products. #J-18808-Ljbffr Verily...Regulatory
- A healthcare technology company in San Francisco is seeking a Staff Regulatory Affairs Engineer. The role involves leading regulatory submissions for AI/ML software, developing regulatory strategies, and ensuring compliance with FDA regulations. The ideal candidate has...Regulatory
- ...seeking a Principal Clinical Engineer - AI Performance & Investigations... ...investigations for AI-driven cardiac SaMD products. You will... ...to determine root causes and regulatory implications. Reporting to the Director of Post‑Market Quality, you will drive CAPAs, risk reviews...SeniorRegulatory
- Heartflow seeks a Senior Manager, Quality System & Compliance to lead the QMS strategy, execution, and continuous improvement... ...with FDA, ISO, EU MDR, and MDSAP across SaMD and device products, guiding audits and regulatory submissions while enabling scalable growth. You...SeniorRegulatory
- ...end-to-end automated testing for its AI-driven SaMD platform. You will define the... ...frontend, backend, 3D modeling, and AI/ML systems, ensuring regulatory compliance and traceability. The role requires 8-12 years in test engineering, deep knowledge of ISO 13485/62304/1...Regulatory
- ...Workday, Inc. is seeking a senior product leader to own a portfolio of AI-driven, enterprise SaaS products. You will partner with engineering, data science, design, and product marketing... ...while remaining aligned with regulatory expectations. #J-18808-Ljbffr Jobleads...SeniorRegulatoryRemote jobContract work
- ...Salesforce seeks a Senior Director of Technology Program Management to... ...Chief Data Officer’s org. This leader oversees portfolio governance across Data/AI/ML platforms, analytics, and enterprise... .... Partner with Product, Engineering, Architecture, Security, and business...Senior
- McKinsey & Company seeks a senior leader to shape and deliver agentic AI and ML solutions for defense clients across public and private sectors, with engagements spanning San Francisco, Silicon Valley, DC, and other US offices. You will guide client service teams, set...Senior
- Scale is seeking a Senior AI Product Manager to build Scale's Cybersecurity portfolio—the data, environments, and evaluation suites used to... ..., task suites, and evaluation products; partner with ML researchers and security practitioners; drive infrastructure and...Senior
$180k - $220k
...Owner Owner is the AI-native system local business... ...of great operators, engineers, and marketers working... ...looking for our first Senior Corporate Counsel to serve... ..., payments and fintech regulatory work, including privacy... ...advising on AI/ML products, with familiarity...SeniorRegulatoryFixed term contractWork at officeLocal areaRemote work- Formation Bio is seeking a Senior Site Reliability Engineer to build and operate the infrastructure, delivery systems, and operational... ...across cloud infrastructure, observability, ML workloads, and production systems in an AI-native environment. You will partner with...Senior
- ...experience that brings AI agents and clinicians... .... The Opportunity: Senior AI Engineer Healthcare is adopting... ...set will define the quality bar for our entire AI... ...designing and scaling ML-powered systems, ideally... .... Understanding of regulatory frameworks like HIPAA...SeniorRegulatory
$160k - $230k
...AirwallexAirwallex is the AI-native... ...the roleAs the Senior Product Manager... ....Partner with Engineering, Data Science... ...informed by high-quality data,... ...for a product leader who is excited... ...or scaling AI/ML-powered products... ...multiple markets and regulatory environments.Why...SeniorRegulatoryTemporary workLocal area- Reflection AI is seeking a senior compliance generalist to turn ambiguous, cross-cutting regulatory challenges into policies, SOPs, training, and monitoring across AI governance, data governance, privacy, and vendor risk. You will partner with pillar leads and the Head...SeniorRegulatory
$232k - $290k
...build real world value.THE WORK:As a Senior Staff Security Engineer focused on AI Security, you will be Ripple's... ...contributing to industry standards, regulatory discussions, and Ripple's published... ...meaningful hands-on exposure to AI or ML security in practice.Solid...SeniorRegulatoryFull timeWork at officeLocal area$139k - $260k
About this role:The Technology AI Transformation team is seeking a Senior Lead Business Execution Consultant to... ...Technology. This role will serve as a key leader in shaping how employees discover,... ..., Financial Crimes, Operational, Regulatory Compliance), which includes...SeniorRegulatoryFull timeWork experience placement- ...research. Generic Scope: Technical leader with a high degree of... ...Pharmacology Laboratory at UCSF seeks a senior quantitative scientist to... ...systems pharmacology, AI/ML, computational biology, and translational... ...with academic, industry, and regulatory stakeholders. The incumbent...SeniorRegulatoryTraineeship
$180k - $230k
Senior Applied AI Engineer $180k - $230k San Francisco Full Time Job Location San... ...Class Team: AI and security leaders from Airbnb, Microsoft,... ...that analyzes thousands of regulatory documents and internal controls... ...reliable, production‑scale ML products. You know how to...SeniorRegulatoryFull timeWork at officeRelocationRelocation packageFlexible hours$136.8k - $142.2k
...transforms outcomes. Sia’s AI & Data Business... ...work directly with senior client stakeholders (CIO, CISO, Engineering leads) to define... ..., data pipelines, ML/DL model serving, generative... ...policies, and regulatory requirements (GDPR,... ...forums to ensure quality and coherence...SeniorRegulatoryPart timeWork at officeImmediate startWorldwide3 days per week$159k - $305k
...Fargo is seeking a Senior Lead Digital... ...enterprise Generative AI capabilities — EMM... ...partnering deeply with engineering, data science,... ...data science, AI/ML, analytics, and design... ...efficiency, model quality, hallucination... ...Crimes, Operational, Regulatory Compliance), which...SeniorRegulatoryFull timeWork experience placementRelocation package- Senior AI Architect - Multi-Agent Systems & Platform Infrastructure... ...Systems & Orchestration / Head of Engineering Seniority: Senior-Level (... ...intelligence. Embed privacy-aware, regulatory-aligned agent workflows (IRS,... ...Collaborate with backend and ML engineers to integrate OpenAI...SeniorRegulatoryFull timeWork at officeRemote work
- OutSystems is seeking a Senior AI Quality Engineer to own quality for our AI-powered product ecosystem. You will define end-to-end testing for AI features, lead automation using Cursor and Claude Code, and shape CI/CD quality gates to catch regressions in code and model...Senior
$286.2k - $326.7k
...Senior Staff AI Engineer (Remote Eligible) At Capital One, we are creating responsible... ...One has been an industry leader in using machine learning to... ..., our applications of AI & ML are bringing humanity and... ...balancing cost, scale, ethics and regulatory compliance ~ Experience...SeniorRegulatoryFull timePart timeLocal areaRemote work$233.6k - $350.4k
...opportunityUnity is shipping AI products into the hands... ...ecosystem, and the ML systems powering ad... ...voice with product and engineering leadership on what Unity... ...converting privacy, IP and regulatory constraints into... ...anddefending them with senior stakeholders.You might...SeniorRegulatoryFull timeTemporary workWork at officeRemote workWorldwideRelocation package$216k - $324k
...company leveraging technology and AI to transform care delivery,... ...in their search for a Senior Privacy & AI Counsel. This role... ...protection, and AI‑related legal and regulatory risks, including supporting... ...‑functionally with product, engineering, or technical teams in a...SeniorRegulatory$136.5k - $261k
...artificial intelligence and machine learning (AI/ML) to Adobe’s product and business teams.... ...advice and guidance to legal, product, engineering, and business teams regarding AI/ML,... ...curiosity and/or knowledge about the emerging regulatory developments affecting AI/ML...SeniorRegulatoryFull timeTemporary workWork at office$140.3k - $260.5k
...business products, and AI/ML to enable fast,... ...As a Senior Data Product Manager... ...autonomous product leader—defining the product... ...Scientists, AI/ML Engineers, and Analysts) to... ...prioritization. Data Quality & Standards Frameworks... ...policies and regulatory standards (e.g., HIPAA...SeniorRegulatoryLocal areaRelocation package3 days per week- ...technology. The flagship product—an AI-driven, non-invasive... ...As the Principal Device Quality Engineer, you will serve as the global... ...as a Medical Device (SaMD) and AI/ML-enabled technologies—are safe... ...security-by-design to global regulatory submissions and post-market...RegulatoryWork experience placementLocal areaWorldwideRelocation
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior SaMD Quality Engineer - AI/ML & Regulatory Leader. Be the first to apply!
- customer quality engineer San Francisco, CA
- supplier quality engineer San Francisco, CA
- senior manager quality engineering San Francisco, CA
- advanced quality engineer San Francisco, CA
- principal quality engineer San Francisco, CA
- senior quality systems engineer San Francisco, CA
- senior supplier quality engineer San Francisco, CA
- senior data quality engineer San Francisco, CA
- quality assurance quality control engineer San Francisco, CA
- program quality engineer San Francisco, CA


