VP of Compliance and Regulatory

XRHealth; Needham (MA); On-site; USD 180,000 - 280,000; Full time

Job summary

XRHealth, a global digital health company, seeks a VP, Compliance and Regulatory to build and lead the compliance function from the ground up in Needham, MA. You’ll design scalable programs addressing HIPAA, SaMD, telehealth, and international data privacy across jurisdictions.

You will partner with Legal, IT, HR, and executives to establish governance, audits, and training, while embedding risk-based processes for rapid growth in a multi-entity organization.

Qualifications

• 10+ years of progressive compliance, regulatory affairs, or healthcare legal experience, with senior leadership exposure.
• JD or equivalent required; healthcare regulatory expertise essential.
• Experience with HIPAA and digital health regulatory frameworks required.

Responsibilities

• Act as internal regulator and lead XRHealth's regulatory strategy across SaMD and telehealth.
• Ensure HIPAA compliance, policies, training, risk assessments, and breach response protocols.
• Lead global data privacy compliance, including GDPR and other regional laws.
• Build and manage compliance programs across XRHealth's entities; support M&A due diligence.

Skills

Regulatory Strategy

HIPAA Compliance

Data Privacy

Cross-functional Leadership

SaMD Knowledge

Education

Juris Doctor (JD)

CHC/CIPP/US or similar

Job description

About XRHEALTH INC

XRHealth is a global leader in immersive healthcare technology, bringing innovative digital therapeutics directly into patients’ homes. Our portfolio includes Medicare-covered virtual reality medical devices (HCPCS E1905), digital therapeutic applications, and AI-powered healthcare solutions that improve the lives of patients living with chronic pain, neurological conditions, mental health disorders, and more.

With over 50,000 patients treated, 1 million+ therapy sessions delivered, and partnerships across Medicare, the VA, commercial payers, employers, and healthcare providers, XRHealth is rapidly expanding its Products business.

Position Summary

XRHealth is seeking a VP, Compliance and Regulatory to build and lead the company's compliance and regulatory function from the ground up. This is a senior, cross-functional leadership role responsible for ensuring XRHealth operates in full compliance with healthcare regulatory requirements, data privacy laws, and corporate governance standards across all jurisdictions in which we operate. The ideal candidate combines deep healthcare regulatory expertise (HIPAA, digital therapeutics/SaMD considerations, telehealth) with international data privacy knowledge (GDPR, Israeli privacy law, Australian Privacy Act) and the ability to design scalable compliance programs for a fast-growing, multi-entity digital health company.

Key Responsibilities

Regulatory Strategy & Healthcare Compliance

• Act as internal auditor and coordinator of XRHealth's regulatory strategy, including monitoring FDA guidance on Software as a Medical Device (SaMD) and digital therapeutics as applicable across operations — this role coordinates and audits strategy
• Ensure ongoing HIPAA compliance across the organization, including policies, training, risk assessments, and breach response protocols
• Monitor and interpret evolving telehealth and digital health regulations across US states and international markets
• Serve as the primary point of contact for regulatory inquiries, audits, and inspections

Data Privacy & Security Compliance

• Lead compliance with global data privacy frameworks, including GDPR (Spain/EU), Israeli Privacy Protection Law, Australian Privacy Act, and US state privacy laws
• Partner with IT/Security to maintain data governance policies, vendor risk assessments, and incident response plans
• Oversee cross-border data transfer mechanisms and ensure appropriate safeguards are in place

Corporate & Employment Compliance

• Build compliance frameworks across XRHealth's three legal entities
• Partner with People Operations on employment law compliance
• Support M&A due diligence and integration from a compliance/regulatory risk perspective
• Maintain and update company policies, codes of conduct, and compliance training programs (including HIPAA and Cultural Competency training)

Program Building & Governance

• Design and implement a scalable, risk-based compliance program appropriate for a growing digital health company
• Establish compliance monitoring, auditing, and reporting cadences to executive leadership and the Board
• Build relationships with outside counsel and external regulatory advisors across jurisdictions
• Develop and manage compliance-related documentation, SOPs, and audit trails

Qualifications

• 10+ years of progressive compliance, regulatory affairs, or healthcare legal experience, with at least 3-5 years in a senior leadership role
• Background as a lawyer with a strong grounding in healthcare regulations required
• Deep working knowledge of HIPAA and US healthcare regulatory frameworks; familiarity with digital therapeutics/SaMD regulatory considerations strongly preferred
• Experience with international data privacy regulation (GDPR required; Israeli or Australian privacy law experience a plus)
• Prior experience in digital health, health tech, medical device, or a comparable regulated industry
• Experience building compliance programs from the ground up in a fast-growing or multi-entity organization
• Strong track record partnering cross-functionally with HR, Legal, Finance, and executive leadership
• JD, compliance certification (e.g., CHC, CIPP/E, CIPP/US), or equivalent advanced degree preferred
• Exceptional judgment, discretion, and communication skills; comfortable operating as a hands-on builder as well as a strategic advisor
• Experience working across international/multicultural teams; Spanish or Hebrew language skills a plus

This job description is intended to convey information essential to understanding the scope of the role and is not exhaustive. Responsibilities may evolve as the company and function grow.