Practice Area
Healthcare IT
Region
Anywhere
Location
Hybrid
Company Location
Philadelphia PA
Position Id
48260

Head of Compliance

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.