This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality & Regulatory Affairs Lead based in United States.
This role offers the opportunity to build and lead the quality and regulatory foundation for an innovative healthcare organization leveraging AI, software, and clinical workflows to improve patient outcomes.
You will own the strategy, implementation, and scaling of a Quality Management System supporting regulated healthcare technologies, including SaMD and AI-enabled solutions.
Working across Product, Engineering, Clinical, Security, Legal, and Operations teams, you will ensure responsible innovation while maintaining compliance and inspection readiness.
This is a hands-on leadership role for an experienced quality and regulatory professional who thrives in complex, fast-moving environments.
You will shape processes, establish best practices, and influence how emerging healthcare technologies are developed and delivered safely.
The role combines strategic vision with operational execution, offering significant impact on both technology and patient care.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Quality & Regulatory Affairs Lead based in United States.
This role offers the opportunity to build and lead the quality and regulatory foundation for an innovative healthcare organization leveraging AI, software, and clinical workflows to improve patient outcomes.
You will own the strategy, implementation, and scaling of a Quality Management System supporting regulated healthcare technologies, including SaMD and AI-enabled solutions.
Working across Product, Engineering, Clinical, Security, Legal, and Operations teams, you will ensure responsible innovation while maintaining compliance and inspection readiness.
This is a hands-on leadership role for an experienced quality and regulatory professional who thrives in complex, fast-moving environments.
You will shape processes, establish best practices, and influence how emerging healthcare technologies are developed and delivered safely.
The role combines strategic vision with operational execution, offering significant impact on both technology and patient care.
Accountabilities:
- Own the Quality Management System strategy and regulatory operating model for software-driven healthcare products, SaMD, AI-enabled solutions, and clinical workflows.
- Lead quality governance across design controls, risk management, CAPA, change control, document control, training, supplier quality, validation, audits, complaint handling, and post-market monitoring.
- Establish processes for patient incident intake, triage, escalation, documentation, investigation, and resolution in collaboration with compliance stakeholders.
- Partner with Product, Engineering, Data Science, Clinical, Security, Legal, and Operations teams to assess regulatory requirements, intended use, risk classification, and compliance needs for evolving capabilities.
- Develop practical, risk-based processes covering software lifecycle management, requirements traceability, verification and validation, usability, AI/ML governance, release readiness, and production monitoring.
- Support regulatory strategies and submissions for AI-enabled medical software, including technical documentation, cybersecurity documentation, regulatory interactions, and applicable FDA pathways.
- Drive QMS effectiveness through management reviews, inspection readiness, audit responses, quality metrics, regulatory commitments, and continuous improvement initiatives.
- 10+ years of progressive experience in Quality Assurance, Regulatory Affairs, Quality Systems, or Quality Compliance, with leadership experience across technical and cross-functional teams.
- Deep experience with regulated software, digital health, SaMD, AI-enabled medical device software, healthcare technology, or medical device environments.
- Strong knowledge of medical device quality systems, including design controls, risk management, CAPA, audits, document control, training, supplier quality, complaint handling, change control, validation, and quality metrics.
- Proven ability to build and operationalize QMS processes, train teams, establish ownership models, and prepare organizations for external audits or inspections.
- Experience with software and AI/ML lifecycle expectations, including verification and validation, model performance evaluation, dataset governance, change control, and post-market monitoring.
- Strong understanding of regulatory and industry standards, including FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, FDA software guidance, cybersecurity expectations, and risk-based quality methodologies.
- Excellent communication, problem-solving, and stakeholder management skills, with the ability to influence technical, clinical, regulatory, and business audiences.
- Ability to operate as a hands-on leader who can build scalable systems while supporting fast-moving product and engineering teams.
- Competitive base salary range of $160,000 – $200,000 per year, depending on location, skills, experience, and qualifications.
- Equity options as part of the total compensation package.
- Fully remote work environment.
- Comprehensive medical, dental, and vision coverage.
- Paid time off.
- 401(k) plan with company matching.
- Paid parental leave.
- Home office stipend.
- Opportunity to contribute to impactful healthcare technology initiatives improving patient care.
As the Quality & Regulatory Affairs Lead, you will be responsible for establishing scalable quality and regulatory frameworks that support AI-enabled healthcare products and technology-driven care models. You will collaborate with cross-functional teams to ensure compliance, manage risks, and enable successful product development and deployment.
Requirements:
The ideal candidate is an experienced quality and regulatory leader with a strong background in healthcare technology, regulated software, and medical device environments. You should combine technical expertise, operational discipline, and strong communication skills to influence teams and build scalable compliance practices.
Benefits: