Compliance Manager

Job not on LinkedIn

🔥 10 hours ago

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

👻 Ghost score 25%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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UpDoc

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

🤖 Artificial Intelligence

☁️ SaaS

💰 Seed on 2024-02

Healthcare • Artificial Intelligence • SaaS

UpDoc is a clinical AI company that provides an enterprise-grade, physician-governed software platform integrated with EHRs and clinical workflows to deliver continuous, evidence-based interventions between visits for chronic disease management. The company emphasizes FDA-cleared, patient-facing large language model (LLM) capabilities, monitoring structured patient data, coordinating with care teams, and operationally embedding into health systems to improve outcomes, adherence, and reduce costs. UpDoc is backed by healthcare organizations and pharmaceutical and advocacy partners (e. g. , Mayo Clinic, Eli Lilly, American Diabetes Association).

📋 Description

• 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

🎯 Requirements

• 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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