Quality & Regulatory Affairs Lead

Vaga não está no LinkedIn

🕒 Julho 27

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $160.000 - $200.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

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Cadence Solutions

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2013

💼 Consultoria

🏢 Corporativo

🤝 B2B

Consulting • Enterprise • B2B

A Cadence Solutions é uma integradora de sistemas e empresa de consultoria focada em gestão da informação e transformação digital. Eles aceleram a adoção corporativa do Microsoft 365, SharePoint (incluindo migrações do SharePoint Online e Server), Microsoft Purview, Power Platform e OpenText. A Cadence oferece implementações de SharePoint, migrações de conteúdo em larga escala (incluindo uma solução de migração chamada Peregrine), verificações de governança e saúde do SharePoint, prontidão para Copilot e governança de dados para Copilot, gestão de registros, eDiscovery, prevenção de perda de dados e treinamentos práticos e workshops de Microsoft 365. Seus serviços estão centrados em consultoria de migração, estratégia de conteúdo, classificação e insights, e ajudam organizações a aplicar as melhores práticas de governança e compliance em ecossistemas ECM e M365.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

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