Deciphex · 1 month ago
Chief Compliance & Risk Officer Med-Tech (East Coast USA only)
United States
Full-time
Remote
Director/Executive
10+ years expDeciphex 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 to meet regulatory standards while leading innovative digital pathology solutions worldwide.
Artificial Intelligence (AI)Health DiagnosticsSoftware
No H1B
Responsibilities
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
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
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
Certified in Healthcare Compliance (CHC) or Certified Compliance & Ethics Professional (CCEP) highly desirable
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
Benefits
Competitive salary with performance based annual increments and bonus.
Professional development
A true sense of meaning in your work by contributing to better patient outcomes.
A chance to work on exciting, challenging and unique projects.
A highly collaborative and supportive multi cultural team.
The opportunity to work alongside a world-class high performing team in a hyper-growth scaling startup environment. (230 folks & growing).
Competitive annual leave
Healthcare benefits and pension with company match
Company
Deciphex
Deciphex builds a network of AI empowered pathologists ensuring accessible pathology services that improves patient outcomes.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$84.87MKey Investors
Claret Capital PartnersMolten VenturesSeroba Life Sciences
2025-10-02Debt Financing· $17.6M
2025-01-07Series C· $32.2M
2023-10-14Debt Financing· $10.51M
Leadership Team
Donal O'Shea
Founder and CEO
Mairin Rafferty
Chief Operations Officer (COO)
Recent News
Silicon Republic
2025-12-18
2025-12-09
Silicon Republic
2025-11-27
Company data provided by crunchbase