Quality & Regulatory Affairs Lead

Cadence Solutions; United States; Remote; USD 160,000 - 200,000; Full time

Benefits offered by this job

Fully remote

Equity options

Comprehensive health coverage

Paid time off

401k plan + matching

Paid parental leave

Home office stipend

Job summary

Cadence is hiring a Quality & Regulatory Affairs Lead to build, scale, and lead the QMS and regulatory strategy for AI-enabled, software-driven healthcare products. This leader will own the quality and regulatory framework for SaMD and technology-enabled care workflows.

You will partner with Product, Engineering, Data Science, Clinical, Security, Legal, Compliance, and external regulators to ensure compliant, scalable development and strong inspection readiness as capabilities evolve.

Qualifications

• 10+ years of progressive experience in QA, RA, QMS, or QA compliance with leadership experience.
• Deep experience in regulated software, digital health, SaMD, AI-enabled medical device software.
• Strong command of medical device QMS processes, including design controls, risk management, CAPA, audits, document control.
• Experienced building and operationalizing QMS processes across teams and audits.
• Experience with software and AI/ML lifecycle expectations, requirements management, verification and validation, risk-based release.
• Deep understanding of FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, cybersecurity expectations.

Responsibilities

• Own QMS strategy and regulatory operating model for AI-enabled healthcare software and SaMD.
• Lead quality system governance across design controls, risk management, CAPA, change control, document control, training, supplier quality.
• Serve as policy governance and patient incident intake, triage, escalation, documentation, closure with Compliance.
• Partner with cross-functional stakeholders to assess use, regulatory pathway, clinical risk, and cybersecurity impact.
• Establish risk-based processes for design controls, V&V, usability, release readiness, AI/ML lifecycle governance.
• Support regulatory strategy and submissions for AI-enabled device software functions (510(k), De Novo, etc.).
• Lead QMS effectiveness, inspection readiness, metrics, CAPA trends, and continuous improvement.

Skills

Quality Assurance

Regulatory Affairs

Quality Systems

Software

AI/ML lifecycle

Regulatory leadership

Tools

CSA

FDA QMSR

Job description

Cadence is the clinical AI company automating the treatment of chronic disease. Its Clinical Intelligence takes on the routine, high-volume work of chronic care – monitoring patients, surfacing risks, and coordinating action – so clinicians can focus on the decisions that require them. Grounded in partnerships with more than 20 leading health systems, deep EMR integrations, dedicated medical group, and experience serving a population of more than 100,000 patients, the system learns from real-world care delivery, improving as it scales. Cadence has been recognized by TIME as one of the Top 100 HealthTech Companies and by LinkedIn as a Top Startup (#4, 2025).

The Role

We’re hiring a Quality & Regulatory Affairs Lead to build, implement, scale, and lead Cadence’s Quality Management System and regulatory strategy for AI-enabled, software-driven healthcare products. This leader will own the quality and regulatory framework for Cadence’s technology-enabled care model, including Software as a Medical Device (SaMD), AI-enabled device software functions, clinical decision support, cloud-based systems, and product workflows that may impact patient care, clinician decision-making, and regulated medical device obligations.

This is a high-impact role hands-on-leadership role for a quality and regulatory leader who can operate at the intersection of AI, software, clinical operations, product development, and medical device compliance. You’ll partner across Product, Engineering, Data Science, Clinical, Operations, Security, Legal, Compliance, and external regulatory advisors to ensure Cadence builds responsibly, scales compliantly, and maintains strong inspection readiness as AI-enabled capabilities evolve.

What You’ll Do

•  Own Cadence’s QMS strategy and regulatory operating model for AI-enabled healthcare software, SaMD, clinical decision support, and technology-enabled care workflows.
•  Lead quality system governance across design controls, risk management, CAPA, change control, document control, training, supplier quality, validation / computer software assurance, audit readiness, complaint handling, and post-market quality monitoring.
•  Serve as process owner for policy governance and patient incident / incident / feedback intake, triage, escalation, documentation, and closure, in close alignment with Compliance leadership.
•  Partner with Product, Engineering, Data Science, Clinical, Security, Legal, Compliance, and Regulatory stakeholders to assess intended use, device classification, regulatory pathway, clinical risk, cybersecurity impact, and QMS requirements for new and evolving software capabilities.
•  Establish practical, risk-based processes for software design controls, requirement traceability, verification and validation, usability / human factors, release readiness, anomaly management, AI/ML lifecycle governance, production monitoring, and post-deployment surveillance.
•  Support regulatory strategy and submissions for AI-enabled device software functions, including 510(k), De Novo, pre-submission interactions, technical documentation, software documentation, cybersecurity documentation, and Predetermined Change Control Plans where applicable.
•  Lead QMS effectiveness, management review readiness, inspection readiness, quality metrics, audit responses, regulatory commitments, CAPA trends, complaint trends, and continuous improvement activities.

What You Need

•  10+ years of progressive experience in Quality Assurance, Regulatory Affairs, Quality Systems, or Quality Compliance, with meaningful leadership experience across software, product, clinical, and technical teams.
• Deep experience in regulated software, digital health, SaMD, AI-enabled medical device software, healthcare technology, or medical device environments.
•  Strong command of medical device QMS processes, including design controls, risk management, CAPA, audits, document control, training, supplier quality, complaint handling, change control, validation / CSA, quality metrics, and management review.
•  Experienced building and operationalizing QMS processes in practice, including training teams, assigning process owners, building usable records, improving policy governance, and preparing for external review or inspection.
•  Experienced with software and AI/ML lifecycle expectations, including requirements management, verification and validation, model performance evaluation, dataset governance, change control, post-market monitoring, and risk-based release decisions.
•  Deep understanding of applicable regulatory and industry requirements, including FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, FDA software guidance, cybersecurity expectations, FDA 21 CFR Parts 803 and 806, and risk-based quality methodologies.
•  A strong operator and communicator with sound judgment, strong escalation instincts, and the ability to influence across technical, clinical, regulatory, compliance, and business audiences. who can build scalable systems, harmonize processes, raise standards, and make quality and regulatory practices usable for fast-moving product and engineering teams.

Compensation

Our job titles may span more than one career level. Salary Range: $160,000 – $200,000 per year. Our salary ranges are determined by role, level, and location. The range displayed represents the minimum and maximum base salary for all US positions across high and low-cost labor markets. An individual’s final pay rate will be based on their geographic location, skills, experience, and relevant education or training.Target Hiring Range: While the full range for this position is $160,000 – $200,000, our anticipated hiring band for most locations is $160,000 – $180,000.Total Compensation: In addition to base salary, this role is eligible for equity options, comprehensive health benefits, a 401(k) match, and a remote work stipend.

Benefits & Perks

• Competitive pay & equity*
• Fully remote
• Comprehensive health coverage: Medical, dental & vision
• Paid time off
• 401k plan + matching
• Paid parental leave
• Home office stipend

*benefit offerings may vary depending on job profile, job level and worker type

Cadence is committed to equal opportunity and fairness regardless of race, color, religion, sex, gender identity, sexual orientation, nation of origin, ancestry, age, physical or mental disability, country of citizenship, medical condition, marital or domestic partner status, family status, family care status, military or veteran status or any other basis protected by local, state or federal laws.