Job Details

Job Description

Client Summary:

• Fast-growing company in the healthcare technology space
• Offers solutions to support remote patient monitoring and at-home care
• Provides a comprehensive platform to streamline operations and care delivery
• Works with a range of vendors and provider organizations
• Currently supports over 80 customers
• Backed by leading investors
• Focused on expanding its provider customer base
• Aims to establish long-term, sustainable growth

Position Responsibilities:
Regulatory & Quality Compliance

• Oversee compliance with FDA regulations (21 CFR Part 11, QSR, MDR, etc.) and DMEPOS accreditation standards.
• Maintain and improve ISO 13485/ISO 9001 quality management systems.
• Manage the development, implementation, and continuous improvement of compliance policies, SOPs, and training programs.
• Lead internal and external audits, ensuring successful outcomes with FDA, CMS, ISO auditors, and other regulatory bodies.
• Partner with operations and product teams to ensure that compliance is embedded in product lifecycle and service delivery.

IT & Data Security Compliance

• Oversee adherence to HIPAA, HITRUST, SOC 2, and other IT security frameworks as relevant.
• Collaborate with IT and Security teams to maintain cybersecurity controls, incident response, and vendor risk management.
• Ensure compliance in handling patient data, PHI, and sensitive company information.
• Drive alignment between compliance and information security initiatives.

Leadership & Strategy

• Advise the executive team and Board on emerging regulatory risks and industry best practices.
• Build and lead a compliance team to support growth and scale.
• Serve as the primary compliance contact for regulators, auditors, and external partners.
• Promote a culture of ethics, compliance, and continuous improvement across the organization.

Experience & Skills:
Required Experience and Qualifications:

• 7+ years of progressive compliance experience, with at least 5 years in a leadership role.
• Strong background in DME compliance, FDA regulations, and ISO standards.
• Proven experience in IT compliance/security frameworks (HIPAA, SOC 2, HITRUST, ISO 27001).
• Deep understanding of healthcare regulations, medical device quality systems, and risk management.
• Exceptional leadership, communication, and cross-functional collaboration skills.
• Ability to thrive in a fast-paced, high-growth healthcare or medtech environment.

Preferred Experience and Qualifications:

• Relevant certifications (e.g., RAC, CHC, CISSP, CISM, ISO Lead Auditor) strongly preferred.