Compliance Manager

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🕒 Outubro 29

🏄 California – Remoto

🏄 California – Remote

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

🚔 Conformidade

👻 Score fantasma 25%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 12 dias.
• 14 vagas abertas para uma equipe de 18 pessoas.
• Sem salário divulgado.

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UpDoc

SiteLinkedInTodas as Vagas

11 - 50 funcionários

🏥 Saúde

🤖 Inteligência Artificial

☁️ SaaS

💰 Seed em 2024-02

Healthcare • Artificial Intelligence • SaaS

A UpDoc é uma empresa de IA clínica que oferece uma plataforma de software de nível empresarial, governada por médicos, integrada com prontuários eletrônicos (EHRs) e fluxos de trabalho clínicos para fornecer intervenções contínuas e baseadas em evidências entre consultas para o gerenciamento de doenças crônicas. A empresa enfatiza capacidades de modelo de linguagem de grande porte (LLM) voltadas para pacientes, aprovadas pela FDA, monitoramento de dados estruturados de pacientes, coordenação com equipes de cuidado, e integração operacional em sistemas de saúde para melhorar resultados, adesão e reduzir custos. A UpDoc conta com o apoio de organizações de saúde e parceiros farmacêuticos e de defesa, como a Clínica Mayo, Eli Lilly e a Associação Americana de Diabetes.

Descrição

• Build and manage UpDoc's compliance foundation across medical device quality and regulatory, health data privacy and security, healthcare fraud and abuse, clinical governance and licensure, and federal research compliance • Partner with the Regulatory and Quality team on compliance requirements intersecting with UpDoc's FDA-regulated product and quality system • Ensure broader compliance policies and processes align with regulatory and quality requirements • Support cross-functional compliance considerations as products, clinical programs, partnerships, and reimbursement models expand • Serve as HIPAA Privacy Officer and coordinate with the Security Officer on the HIPAA Security program • Own Business Associate Agreements, minimum-necessary practices, breach assessment and notification procedures, and data flow documentation • Partner with Security on SOC 2 Type II and HITRUST readiness and lead responses to health system vendor risk assessments • Advise on federal and state privacy requirements, including HIPAA, CCPA/CPRA, and emerging health data privacy laws • Build compliance frameworks for care management, remote monitoring, and other reimbursement pathways • Assess arrangements under the Anti-Kickback Statute, Stark Law, and beneficiary inducement rules with outside counsel • Maintain Corporate Practice of Medicine compliance across operating states • Establish and oversee clinician credentialing, licensure, scope of practice, and supervision requirements • Ensure care is documented, escalated, and audited according to clinical governance standards and partner health system requirements • Support federally funded research and grant compliance, including human subjects protections, IRB coordination, data management, and cost allowability • Maintain conflict of interest and research integrity policies • Write, maintain, and train the company on policies and procedures • Lead the annual compliance risk assessment and work plan • Establish compliance training, reporting mechanisms, and audit and monitoring cadence • Prepare regular compliance and risk reporting for the CEO and Board • Serve as primary compliance counterpart to customer legal, privacy, and IT security teams during contracting and implementation • Coordinate with outside counsel, auditors, and specialized advisors

🎯 Requisitos

• 8+ years of healthcare compliance experience, with at least 3 years in a leadership or program-owner role • Experience working with FDA-regulated software or digital health products, with a strong understanding of SaMD quality systems and post-market obligations • Deep working knowledge of HIPAA Privacy and Security Rules and experience negotiating BAAs with health systems • Experience supporting SOC 2, HITRUST, or comparable healthcare security and compliance frameworks • Familiarity with Medicare care management reimbursement compliance and healthcare fraud and abuse law • Track record of building programs from an early stage rather than solely administering mature ones • Ability to translate regulation into pragmatic guidance for engineers, clinicians, and executives, and to hold a firm line when it matters • Experience at a digital health or clinical AI company selling into large health systems or academic medical centers • Exposure to federal research compliance, including NIH, ARPA-H, or similar federally funded programs • Familiarity with AI-specific regulatory developments, including FDA guidance on AI-enabled device software and predetermined change control plans • Certification such as CHC, CHPC, CIPP/US, or RAC • JD, MPH, MHA, or equivalent graduate training is strongly preferred; a clinical background is a plus • Must be currently authorized to work in the United States without employer sponsorship

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