VP of Compliance and Regulatory

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

Job summary

XRHealth INC is seeking a VP of Compliance and Regulatory to build and lead the company’s compliance and regulatory function from the ground up. This senior role ensures adherence to HIPAA, global data privacy laws, and governance standards across jurisdictions, guiding strategy and audits.

The ideal candidate will bring a JD or compliance credentials, 10+ years in healthcare regulatory affairs, and a track record of establishing scalable programs in fast-growing multi-entity settings.

Qualifications

• 10+ years in compliance, regulatory affairs, or healthcare law.
• Senior leadership experience in regulated environments.
• Strong HIPAA and digital health regulatory knowledge.
• Experience with international data privacy laws (GDPR, etc.).
• Experience building programs from ground up in fast-growing orgs.

Responsibilities

• Lead regulatory strategy and ensure HIPAA and telehealth compliance.
• Serve as primary contact for audits, inquiries, and inspections.
• Oversee data privacy programs across global jurisdictions.
• Build and manage compliance frameworks across XRHealth's entities.
• Develop scalable governance, policies, and audit trails.

Skills

Regulatory strategy

HIPAA compliance

Data privacy

Auditing

Cross-functional leadership

Regulatory liaison

Legal collaboration

Education

Juris Doctor (JD)

Compliance certification (CHC/CIPP-US)

Job description

VP of Compliance and Regulatory

XRHEALTH INC Needham, Massachusetts, United States

About this position

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.