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Deciphex · 1 day ago

Chief Compliance & Risk Officer Med-Tech (East Coast USA only)

United States

Full-time

Remote

Director/Executive

10+ years exp

Deciphex is a leading digital pathology company developing AI-powered diagnostic systems for medical laboratories. They are seeking a visionary Chief Risk and Compliance Officer to shape and enhance strategies ensuring compliance with regulatory standards and support commercial growth within the digital pathology sector.

Artificial Intelligence (AI)Health DiagnosticsSoftware

No H1B

Responsibilities

Deciphex is seeking a visionary Chief Risk and Compliance Officer, who will serve as a member of the Senior Leadership Team

Your role will be at the forefront of shaping and enhancing our strategies to ensure we meet the highest regulatory standards, and the expectations of leading innovative, cutting edge digital pathology software products and solutions worldwide

In this role, you will operate as an independent, authoritative executive leader (effectively the CEO of risk and compliance) with the mandate, credibility, and organisational standing to lead and protect the company’s long-term value, regulatory position, and strategic optionality

You will set and own the enterprise-wide strategy for risk, compliance, and regulatory enablement, exercising independent judgement over priorities, sequencing, and resourcing, and advocating for the investments required to deliver the agenda

Ensuring they actively support, rather than constrain, commercial growth, platform deployment, and corporate optionality

The role will involve driving the activities of Deciphex’s Compliance Team in accordance with principles of ‘compliance by design’, architecting scalable regulatory, quality, and governance frameworks; while also enabling global medical clinical services, AI diagnostic or medical device commercialization, IP licensing models, and potential future divestiture scenarios

Champion and drive Deciphex’s global regulatory vision and strategy, shaping the future of our products and services across every market we serve

Elevate and evolve our global compliance and enterprise risk program, proactively managing risks, strengthening controls and governance, driving continuous improvement, and championing a culture of integrity and organizational resilience

Act as an independent executive voice on enterprise risk, empowered to challenge strategic decisions, timelines, and delivery approaches where regulatory, ethical, or long-term value considerations require course correction

Proactively define compliance and risk priorities, resource requirements, and sequencing, and advocate at executive and Board level for the funding, talent, and organisational focus required to execute effectively

Architect risk-based compliance frameworks that balance regulatory rigor with speed of execution, supporting scale from growth-stage company to global platform business

Design and oversee compliant corporate and regulatory structures that enable IP licensing, third-party platform deployment, and separation of R&D, product, and clinical service operations where appropriate

Partner with Finance and Legal to establish intercompany licensing, governance, and compliance models that support strategic transactions, partnerships, and future divestiture optionality while maintaining regulatory integrity

Provide senior regulatory input into corporate structuring decisions to ensure alignment with medical device, AI, data protection, and laboratory regulatory expectations across jurisdictions

Provide strategic oversight for global AI-based medical device compliance, guiding EU AI Act readiness, international medical device regulations (EU IVDR/MDR, FDA, UK MHRA), and global privacy requirements

Oversee the design and deployment of scalable quality and validation frameworks (including software lifecycle controls and post-market surveillance) through delegated operational leads, rather than direct execution

Support regulatory submissions, clinical validation strategies, and lifecycle compliance for Deciphex’s AI-enabled diagnostic platforms

Provide strategic leadership and oversight for our accredited laboratory and clinical service operations

Empower the Quality and Regulatory team to uphold and advance our UK (CQC, UKAS, ISO 15189) and US (CAP, CLIA) certifications, and ensuring we deliver world-class standards across all markets

Champion and lead Deciphex's US federal healthcare compliance, OIG requirements, and multi-jurisdictional US regulatory frameworks governing adoption of innovative digital pathology service solutions

Ensure alignment between clinical service compliance obligations and broader enterprise risk and medical device strategies

Empower and lead the Compliance Team (Quality, Regulatory and Data Protection team), fostering a culture of integrity through training, enablement, and close partnership with Legal, IT Security, HR, Finance, Research, Technology, Commercial and Operations

Act as the primary escalation point for integrity and compliance issues and oversight of confidential investigations with objectivity and discretion

Engage and advise senior leadership, including regular updates to the Executive Board and the Board’s Audit Committee, on compliance risks as well as the performance and strategic direction of the global Compliance Program

Collaborate with internal and external stakeholders, including regulators and key opinion leaders, to anticipate regulatory changes, align compliance efforts to ensure Deciphex remains at the forefront of delivering innovative solutions and services in a dynamic global healthcare market

Qualification

Compliance leadershipHealthcare complianceRegulatory strategyAI complianceCertified Healthcare ComplianceISO 13485IVDR/MDR understandingFDA regulationsStakeholder engagementComplianceStrategic planningLeadership experienceIntegrity

Required

Minimum 10 years progressive compliance experience in healthcare or med tech industry

Minimum 5 years in senior compliance leadership role

Advanced degree in healthcare administration, compliance, or related field

Certified in Healthcare Compliance (CHC) or Certified Compliance & Ethics Professional (CCEP) highly desirable

Substantial leadership experience, including within integrity and compliance

Ability to build trust and respect with internal and external stakeholders, positively influencing and fostering integrity and compliance

Understanding of: IVDR/MDR, FDA, ISO 13485 (legal entity perspective)

Practical experience validating software/AI in regulated environments

Understanding of AI Act requirements, IVDR pathways, FDA 510(k) process, ISO 13485 etc

Strategic regulatory planning experience (not just compliance execution)

Substantial leadership experience, including within integrity and compliance

Preferred

Enthusiastic with genuine interest in science and technology

Expert understanding of OIG Compliance Programs, Medicare/Medicaid regulations and reimbursement with track record of building compliance programs from ground up

Knowledge of Federal Anti-Kickback Statute, Stark Law, False Claims Act, HIPAA Privacy and Security Rules

Understanding of EU AI Act and emerging AI regulations

Experience in managing complex integrity and compliance investigations using methods and procedures which ensure confidentiality, accountability, and objectivity