Head of Compliance jobs in United States
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Impilo · 3 hours ago

Head of Compliance

positionPhiladelphia, PA
timeFull-time
remoteOnsite
seniorityDirector/Executive
date7+ years exp

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.

Health CareHospitalMedical Device

Responsibilities

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
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
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

Qualification

DME complianceFDA regulationsISO standardsIT compliance frameworksHealthcare regulationsRisk managementLeadershipContinuous improvementCertifications RACCertifications CHCCertifications CISSPCertifications CISMCertifications ISO Lead AuditorCommunicationCross-functional collaboration

Required

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

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

Benefits

Competitive compensation
Equity
Benefits package

Company

Impilo

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Impilo provides remote care logistics and patient support solutions.
dateFounded in 2020
location
Philadelphia, Pennsylvania, USA
people-size11-50 employees
web-link
https://www.impilo.health

Funding

Current Stage
Early Stage
Total Funding
$17.5M
Key Investors
Construct Capital2048 Ventures
2024-11-14Series A· $11.5M
2024-02-15Seed
2023-02-08Seed· $4.5M

Leadership Team

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Josh Stein
Founder
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Recent News

PR Newswire
Introducing "TaylorAI," Impilo's Digital Health Concierge Agent
2026-01-12
PR Newswire
Impilo Announces Major Warehouse Expansions to Support Long-Term Growth
2026-01-07
GlobeNewswire
Medical Device Testing Market Expected to Surpass USD 24.32 Billion by 2034
2025-12-08
Company data provided by crunchbase