Head of Compliance

2 hours ago

Philadelphia, Pennsylvania, United States Impilo Full time

Director of Compliance

Location: On site in Bridesburg, Philadelphia

Department: Compliance & Risk Management

Reports To: Chief Operating Officer / Chief Executive Officer

Position Summary

Impilo is seeking a Director of Compliance to lead our regulatory, quality, and IT compliance programs. This role will ensure that our organization maintains full adherence to Durable Medical Equipment (DME) regulations, FDA requirements, ISO standards, and IT security/compliance frameworks. The ideal candidate has deep knowledge of healthcare compliance, experience managing audits, and the ability to build a culture of integrity and accountability across the company.

Key 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.

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

Why Join Impilo?

  • Mission-driven team improving access and quality in healthcare.
  • Opportunity to shape compliance programs at scale.
  • Collaborative, innovative, and growth-oriented culture.
  • Competitive compensation, equity, and benefits package.

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