Quality & Regulatory Affairs Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Take charge of Cadence's Quality Management System (QMS) strategy and regulatory operating model for AI-enhanced healthcare software, Software as a Medical Device (SaMD), clinical decision support systems, and technology-driven care workflows.

• Direct quality system governance, focusing on design controls, risk management, Corrective and Preventive Actions (CAPA), change control, document management, training, supplier quality, validation/computer software assurance, audit readiness, complaint management, and post-market quality oversight.

• Act as the process owner for policy governance, patient incident handling, feedback intake, triage, escalation, documentation, and resolution, in close collaboration with Compliance leadership.

• Collaborate with Product, Engineering, Data Science, Clinical, Security, Legal, Compliance, and Regulatory teams to evaluate intended use, device classification, regulatory pathways, clinical risk, cybersecurity implications, and QMS requirements for new and evolving software functionalities.

• Develop practical, risk-based procedures for software design controls, requirements traceability, verification and validation, usability/human factors, release readiness, anomaly management, AI/ML lifecycle governance, production monitoring, and post-deployment surveillance.

• Assist with regulatory strategies and submissions for AI-enabled software functions, including 510(k), De Novo submissions, pre-submission interactions, technical documentation, software documentation, cybersecurity documentation, and Predetermined Change Control Plans where applicable.

• Oversee QMS effectiveness, management review readiness, inspection preparedness, quality metrics, audit responses, regulatory commitments, CAPA trends, complaint trends, and activities aimed at continuous improvement.

⛳️ Requirements

• A minimum of 10 years of progressive experience in Quality Assurance, Regulatory Affairs, Quality Systems, or Quality Compliance, with substantial leadership experience spanning software, product, clinical, and technical teams.

• Extensive experience in regulated software environments, digital health, SaMD, AI-enabled medical device software, healthcare technology, or medical device sectors.

• Proficient understanding of medical device QMS processes, including design controls, risk management, CAPA, audits, document control, training, supplier quality, complaint handling, change control, validation/computer software assurance, quality metrics, and management reviews.

• Proven track record in building and operationalizing QMS processes, including training teams, designating process owners, creating usable records, enhancing policy governance, and preparing for external reviews or inspections.

• Familiarity with software and AI/ML lifecycle expectations, covering requirements management, verification and validation, model performance assessment, dataset governance, change control, post-market monitoring, and risk-based release decisions.

• Thorough understanding of relevant regulatory and industry standards, including FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, FDA software guidance, cybersecurity requirements, FDA 21 CFR Parts 803 and 806, and risk-based quality methodologies.

• A strong operator and communicator with sound judgment, excellent escalation instincts, and the ability to influence a diverse range of technical, clinical, regulatory, compliance, and business stakeholders, capable of developing scalable systems, harmonizing processes, elevating standards, and making quality and regulatory practices accessible for fast-paced product and engineering teams.

🏝️ Benefits

• Competitive pay & equity*

• Fully remote

• Comprehensive health coverage: Medical, dental & vision

• Paid time off

• 401k plan + matching

• Paid parental leave

• Home office stipend