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.
Represent the reviewer's perspective across our document intelligence platform, ensuring alerts and workflows provide genuine value.
Lead discovery and validation sessions, translating reviewer needs into workflows, user stories, and acceptance criteria.
Test completed capabilities from a reviewer's perspective to identify missing requirements and workflow gaps.
ICA, Inc. is a rapidly growing D.C.-area company founded in 2009 that helps government clients with research, data science, and strategic services. Our small company prioritizes work-life balance and a collaborative 'one team' culture.
Support software design assurance for cloud-based, data platform, and AI/ML-enabled systems.
Lead pre-market risk management deliverables including Software Hazard Analysis and design FMEA.
Review and approve design control deliverables and support post-market activities and CAPA.
Dexcom is a pioneer and global leader in continuous glucose monitoring (CGM), creating biosensing technology to improve health outcomes. The company is driven by thousands of ambitious, passionate employees worldwide who focus on listening, integrity, and dependability.
Review de-identified patient records, clinical notes, and model responses; label them against clear guidelines.
Write and refine grading rubrics and reference answers for clinical reasoning tasks.
Grade AI model outputs for accuracy, safety, and clinical usefulness, and flag ambiguous cases.
GenMD is a Stanford spin-off building AI and data infrastructure for healthcare. We're a small, well-funded, revenue-generating team fresh out of stealth, moving fast and focused on building something fundamental.
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.
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.
Prepare and maintain core medical device training courses, including MDR/IVDR/ISO13485/MDSAP.
Support peer reviews and assessments for trainee exercises to ensure conformity assessment understanding.
Schedule training sessions and track the progression and qualification status of new trainees.
SGS is the world's leading testing, inspection and certification company, recognized as a global benchmark for sustainability and quality. With 99,600 employees across 2,600 offices, we offer a dynamic, international culture and long-term development opportunities.
Audit AI 'Chain-of-Thought' reasoning for medical diagnostics to ensure adherence to international clinical protocols.
Rigorously verify AI-generated drug interactions, dosage recommendations, and contraindications against peer-reviewed medical literature.
Precisely label complex biomedical datasets—including MRI/CT scans, pathology reports, and genomic data—to improve model visual-spatial reasoning.
TELUS Digital is a technology company that helps businesses collect, enhance, train, translate, and localize content to build better AI models. They have a global AI community of over one million contributors from diverse backgrounds, fostering a culture of flexibility and innovation.
Review anonymised conversations with Ash and judge, as a clinician, whether it handles key moments well.
Explain your reasoning on what Ash should do, what could go wrong, and why.
Work alongside experienced clinicians without contacting users, helping shape what great looks like.
Slingshot AI is the team behind Ash, the first AI designed for mental health, making support more accessible. It's a well-funded Series A company with $93M raised, offices in NYC and London, and a culture of autonomy, flexibility, and care.
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.
Provide customers with onsite and remote consulting and education to implement Intuitive medical technology best practices.
Collaborate with hospital stakeholders and Intuitive ecosystem partners to launch and sustain da Vinci and Ion programs.
Ensure compliance with regulations and standards for reprocessing reusable medical devices.
Intuitive is a pioneer and market leader in robotic-assisted surgery, united behind the mission that minimally invasive care is life-enhancing care. With over 25 years of experience, the company fosters an inclusive and diverse team, investing in employees' long-term growth and well-being.
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.
You'll review AI-generated outputs for clinical accuracy, safety, and appropriateness across Headway's patient and provider products.
You'll apply and refine evaluation rubrics, documenting your clinical reasoning and collaborating with peers on ambiguous cases.
You'll work with Clinical and Product teams to turn feedback into rubric and model improvements, ensuring high standards before launch.
Headway builds a new mental healthcare system that automates insurance admin and gives therapists tools to run their practice. We are a Series D company with $325M+ in funding, supporting 85,000+ providers and 1M+ patients across all 50 states.
Serve as a technical lead and device subject matter resource across the medical device total product life cycle.
Analyze premarket and postmarket submissions, evaluating safety, effectiveness, and benefit-risk determinations.
Develop SOPs, real-world evidence protocols, and risk standards grounded in FDA guidance while mentoring junior engineers.
ICA, Inc. is a rapidly growing government consulting firm providing innovative solutions in public health research, advanced data science, and strategic services. Our small but collaborative team prioritizes work-life balance and supports dynamic, highly skilled professionals.
Build the platform that powers our care teams, from first idea to production.
Work directly with physicians and members to ship features that improve real health outcomes.
Use AI coding agents to own architecture, security, and deployment end to end.
PrimaryMD is a concierge medical practice that combines primary care, urgent care, and longevity medicine with a proprietary technology platform to deliver proactive, personalized care. The company is scaling quickly, tripling care capacity in under six months, with a small, senior team that values ownership, direct feedback, and AI-native development.
Develop reference solutions that document procedures, evidence, findings, and justified conclusions.
Evaluate agents on supporting documents, transaction testing, workpapers, and professional skepticism.
Anyone AI develops AI agents to perform audit workflows and exercise evidence-based judgment. They operate as a remote, project-based company with flexible hours for contractors.
Review de-identified medical images across multiple modalities
Provide expert diagnostic reads and clinical interpretations
Apply structured scoring rubrics to clinical cases
Terac is building the world's largest pool of vetted human experts for AI. Researchers, AI labs, and product teams use Terac to recruit, screen, and pay study participants across industries, languages, and skill sets.
Own the safety standard for AI-generated clinical content, defining what counts as a hallucination, omission, or clinically material error.
Design and run evaluation protocols, build grading rubrics, and classify failures by severity to enforce the release gate.
Spend 5-10% of time building clinical modules and joining sales conversations to explain safety validation to clinical leaders.
Avo is the leading AI platform for healthcare enterprises, helping clinicians make better decisions and improve patient care. The company is remote-first, product-obsessed, and collaborative, backed by investors including Noro-Moseley Partners, AlleyCorp, and Scrub Capital.
Review de-identified clinical cases and pharmaceutical product images.
Develop scoring rubrics and provide written expert evaluations.
Assess accuracy of medical data interpretations for AI benchmarking.
Terac is building the world's largest pool of vetted human experts for AI. Researchers, AI labs, and product teams use Terac to recruit, screen, and pay study participants across industries, languages, and skill sets.
Embed with business and clinical teams to learn workflows and identify where AI can reduce manual work.
Ship production-quality AI tools that turn six-to-eight-hour tasks into under thirty minutes, using telemetry and privacy-by-design.
Drive adoption until teams run the tools independently, then turn learnings into reusable building blocks.
Rula is a mental health care company making mental healthcare work for everyone through evidence-based, compassionate care. It is remote-first, inclusive, and hires across most U.S. states.