Senior Director, Compliance & Regulatory Affairs

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OpenLoop

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

💼 Consulting

⚖️ Legal

📦 Logistics

💰 $15M Series A - OpenLoop Health on 2023-03

Consulting • Legal • Logistics

OpenLoop is a white-label telehealth platform and managed services provider that helps organizations launch and scale virtual care programs. It combines SaaS-based, brandable technology (scheduling, booking, payments, EHR/API integrations) with clinical staffing, credentialing, payer coverage and RCM, regulatory/legal support, and 24/7 patient support. OpenLoop serves health plans, hospitals and health systems, retailers, employers and digital health companies with AI-powered operations, a nationwide clinician network and broad insurance coverage including Medicare and Medicaid.

📋 Description

• Compliance program design & oversight: Stand up and maintain all seven OIG elements as an effective, documented compliance program — you own written standards, training and education, and program oversight directly. Serve as the designated compliance officer for regulators, payors, and auditors. • Policy, governance & standards: Own the policy and SOP lifecycle — authoring, versioning, attestation, and retirement across all OpenLoop subsidiaries. Maintain the governance framework and map all policies to OIG, FDA, GDPR, and CMS controls. • Privacy & data protection (HIPAA/GDPR): Own the HIPAA Privacy and Security programs; manage breach response from detection through notification and documentation. Serve as or directly support the GDPR Data Protection Officer function. • Investigations, ethics & screening: Oversee the hotline and investigation program — intake, triage, root-cause analysis, corrective action, and self-disclosure workflow. Own the exclusion and sanction screening program and administer the conflict-of-interest program. • FDA & regulatory affairs: Establish quality-system and promotional controls for regulated device, diagnostic, and SaMD components. Track FDA regulatory status for RPM devices and connected-health components, and maintain the Stark Law and non-monetary compensation tracking program. • Training, education & culture (OIG Element 3): Personally hold OIG Element 3 — design and maintain the compliance training curriculum across the workforce and clinician network, and set the cultural tone that compliance is infrastructure, not obstacle. • Team leadership & governance: Manage the Healthcare Investigations Manager, Policy & Governance Manager, Exclusion & Sanction Screening Lead, and HIPAA & Privacy Compliance Manager. Oversee the Conflict of Interest Program Administrator and Stark Law & Non-Monetary Comp Analyst. Prepare board and leadership reporting on program status, risk posture, and open corrective actions.

🎯 Requirements

• 12+ years in healthcare compliance, regulatory affairs, or health law, with end-to-end compliance program ownership — you've run it, not just contributed to it. • Deep working knowledge of the OIG Seven Elements framework. • HIPAA Privacy and Security program ownership; GDPR experience strongly preferred. • FDA regulatory experience (device, SaMD, or digital health) a strong plus. • Experience managing and developing a compliance team in a multi-state, technology-forward healthcare or pharmacy-adjacent environment. • Familiarity with the telehealth regulatory landscape — multi-state practice authority and prescribing rules. • CHC, CHPC, CCEP, or equivalent compliance credential preferred. • Executive presence and sound judgment; comfortable being named as the responsible executive in regulator-facing documentation. • High integrity, low-ego collaborator who can influence across Legal, Product, Security, and Clinical.

🏖️ Benefits

• Medical, Dental, and Vision plans • Flexible Spending/Health Savings Accounts • Flexible PTO • 401(k) + Company Match • Life Insurance, Pet insurance, and more