Review and approve validation of software and AI products to ensure full compliance with regulatory requirements and company policies.
Prepare for and support external regulatory audits; lead internal or vendor audits related to maintaining GxP and regulatory compliance.
Develop and maintain digital/software components of quality management systems, including AI quality management systems.
Care Access brings world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, they are reimagining how clinical research and health services reach the world.
Assess manufacturers' software lifecycle processes and technical documentation for medical device software, including SaMD and AI-enabled devices, under EU MDR, UK MDR, and relevant IEC standards.
Raise and close out technical assessment findings with manufacturers, explaining regulatory requirements clearly and constructively.
Deliver consistent, high-quality assessments that match Scarlet's methodology and values, working independently with flexible scheduling.
Scarlet is a medical technology certification company that combines clinical, technical and regulatory expertise with AI agents and software to help ambitious technology companies certify AI-enabled medical devices faster without lowering safety standards. You'll join a collaborative team building the infrastructure that makes rigorous certification repeatable at scale.
Define and lead end-to-end quality strategy for SaMD software, AI/ML models, and connected-device products.
Own software V&V strategy, ensuring traceability and regulatory compliance across web, mobile, backend, and firmware.
Embed quality into the SDLC with shift-left practices, CI/CD gates, and automated regression testing.
Sword Health builds AI-powered healthcare care programs, using AI to heal billions and remove barriers to care. With 700,000+ members, 1,000+ enterprise clients, and $500M+ raised, Sword is a fast-paced, clinical-focused AI lab.
Guide product teams through FDA regulatory pathways for Class II/III medical device software.
Develop U.S. and international submission packages and integrate technical evidence.
Collaborate with cross-functional teams to maintain compliance and respond to agency questions.
A partner company in the medical device industry seeking a regulatory affairs expert for software products. The company values collaboration across engineering, quality, and product teams to ensure compliant and defensible FDA submissions.
Build and deploy AI solutions that reduce administrative burden and improve care management.
Implement intelligent automation for scheduling, care plan updates, and post-visit tasks.
Integrate AI solutions with existing EHR and resident management systems while ensuring HIPAA compliance.
Curana Health is a national leader in value-based care for senior living communities and skilled nursing facilities, providing on-site primary care, ACOs, and Medicare Advantage plans. Founded in 2021, the company has over 1,000 employees and serves 200,000+ seniors across 32 states, with a culture focused on collaboration and improving senior care.
Ensures supplier compliance with ISO 13485, MDSAP, and EU MDR regulations.
Conducts supplier audits as Lead Auditor and owns supplier quality processes, SCARs, and CAPAs.
Partners with cross-functional teams to improve supplier controls and supports regulatory inspections.
Intuitive Surgical is a global leader in minimally invasive care, best known for its da Vinci surgical systems. The company values quality, compliance, and innovation, with a cross-functional and engineering-driven culture.
Lead design and development of complex software systems, including AI-powered capabilities like semantic search and RAG architectures.
Collaborate cross-functionally to translate business requirements into scalable, maintainable technical designs.
Mentor and coach engineers while championing AI-assisted development tools and best practices.
OnBoard provides board management software that helps boards function at a higher level so organizations can make a bigger difference in the world. Serving more than 5,000 organizations and 12,000 boards worldwide, OnBoard is a growing, casual, fun, and philanthropic company backed by JMI Equity.
Lead end-to-end delivery of complex healthcare AI products, including agentic workflows, RAG systems, and production services.
Collaborate with Product, Engineering, Data, and clinical teams to translate stakeholder needs into validated, access-aware AI workflows.
Own evaluation frameworks, model optimization, and human-review controls to keep high-stakes workflows safe, reliable, and governable.
NeueHealth is a value-driven healthcare company that aligns the interests of health consumers, providers, and payors to make healthcare accessible and affordable. They deliver clinical care through owned clinics and provider partnerships while enabling performance-based care with technology and services.
Be the AI/ML subject matter expert, shaping strategy and best practices.
Implement AI/ML solutions, write clean code and unit tests, and create documentation.
Collaborate in an Agile team with 2-week sprints, participating in code reviews and client meetings.
Smile Digital Health provides a FHIR-based data liberation platform that helps healthcare stakeholders collect and exchange data, used in over 20 countries. They foster a culture of respect, inclusion, and belonging, valuing diversity and empowering employees to bring their authentic selves to work.
Drive licensing applications end-to-end through multi-month regulatory programs.
Build program plans, coordinate cross-functional teams, and manage risks across active markets.
Leverage AI to automate reporting and define scalable program standards for global policy.
Circle builds the foundation of a more open global economy through digital assets, payments, and blockchain infrastructure. It's a publicly traded company with a flexible, stakeholder-driven culture focused on integrity and innovation.
Design retrieval architectures and build AI-powered agents for healthcare intelligence.
Own production deployments and on-call support for HIPAA-compliant systems.
Partner with product, data science, and clinical teams to deliver AI at scale.
Cohere Health builds a clinical intelligence platform with AI-powered solutions that streamline payer-provider decision-making in healthcare. The company has been recognized on the Inc. 5000 list and as a top LinkedIn startup, with a collaborative, empathetic culture.
Lead the development and execution of Computer System Validation (CSV) and Computer Software Assurance (CSA) strategies, plans, and protocols.
Ensure GxP-regulated systems comply with FDA, ISO, and other global regulatory requirements through risk-based validation and documentation.
Collaborate with IT, Quality, Engineering, and Manufacturing teams to support compliant system implementations and lifecycle management.
The company is a technology-driven organization in the healthcare and life sciences sector, focused on ensuring the safety, quality, and reliability of computerized systems used in regulated environments. It fosters a collaborative culture that values continuous improvement, professional growth, and cross-functional teamwork.
Design and build security solutions across application security, infrastructure, and AI agentic systems.
Secure integrations, manage secrets, and review public-facing APIs for vulnerabilities.
Develop AI governance standards and security review agents to protect user trust.
Wave builds mobile financial services across Africa, making cash deposits, withdrawals, and payments accessible to millions. With a rapidly growing team in 9 countries and a remote-first culture, Wave fosters autonomy and ownership.
Represent the practice directly with customers through calls, webinars, and conferences to drive deals.
Map compliance frameworks like GDPR, NIST, PCI, and HIPAA to Zscaler capabilities control by control.
Build reusable playbooks and educate field teams to handle compliance conversations while protecting data.
Zscaler accelerates digital transformation by securing users, devices, and applications anywhere with its Zero Trust Exchange platform. The company operates the world's largest in-line cloud security platform across 200+ data centers, fostering a culture of ownership, collaboration, and customer obsession.
Design and maintain secure architectures across AWS, Azure, and GCP with infrastructure-as-code and policy-as-code enforcement.
Secure AI/ML pipelines and LLM applications, addressing OWASP Top 10 for LLMs and implementing guardrails and content-filtering controls.
Drive security operations, including SIEM monitoring, incident response, and supporting HIPAA/HITRUST/SOC 2 compliance.
Reveleer delivers a unified platform for risk adjustment, quality improvement, clinical intelligence, and member management for health plans and provider organizations in value-based care. Trusted by 80+ customer organizations nationwide, the company fosters a collaborative, compliance-focused culture with transparent, human-in-the-loop AI at its core.
Lead end-to-end design for complex audit workflows, from problem definition to shipped solutions
Partner with Product and Engineering to shape strategy, influence roadmaps, and deliver scalable implementations
Drive design execution with minimal direction and advocate for users within technical and business constraints
Fieldguide is building software for assurance and audit practitioners, streamlining cybersecurity, privacy, and financial audits. As an early-stage, remote-first startup, we value diversity and maintain an inclusive, driven, and supportive culture.
Serve as senior security engineering partner for AI product initiatives, working side by side with AI engineers from architecture through production.
Design, build, and secure AI-enabled applications, including agents, MCP servers, RAG pipelines, and cloud foundations with identity, data protection, and observability.
Partner with Privacy, Compliance, and Legal to meet healthcare security requirements, and coach developers on secure paved-road patterns.
Abacus Insights is transforming how data and AI work for health plans, helping them break down data silos to create a trusted data foundation. Backed by $100M from top investors, the company is collaborative, bold, and curious, embracing the thoughtful use of AI and automation.