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

Deciphex • East Coast ONLY, MA

16d

About The Position

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. The role will also line-manage the existing, highly experienced Quality, Regulatory and Data Privacy teams, who have established our existing QMS and compliance landscape for our products and services.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• Enterprise Risk, Compliance & Governance Strategy Champion and drive Deciphex’s global regulatory vision and strategy, s haping 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 t hat balance regulatory rigor with speed of execution, supporting scale from growth-stage company to global platform business.
• Corporate Structure, IP & Strategic Optionality 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.
• Global Medical Device & AI Compliance 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.
• Clinical & Laboratory Services Compliance 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.
• Leadership, Oversight & Engagement 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, o n 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 101-250 employees