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

📍 Location & Travel

• EAST COAST USA TIMEZONE ONLY (due to our regions/ teams)
  
• The role will be primarily USA East Coast remote with regular collaboration across our global teams particularly in European time-zone online meetings. 
• Quarterly travel to Dublin (Ireland) is expected, with periodic travel to other Deciphex locations. 
• Occasional out-of-hours support for urgent compliance needs would be part of the dynamic international environment.

Eligibility to work in USA

• Unfortunately, we cannot offer USA work permits or USA visa sponsorship
• Candidates will already hold the right  work in USA at the time of application.

🏢 About us

Deciphex is a leading digital pathology company developing AI-powered diagnostic systems for medical laboratories.

With clinical services operations spanning the EU, UK, US, and Canada (offices in Dublin, Exeter, Oxford, Toronto, and Chicago), Deciphex delivers innovative solutions for pathology workflow optimization and AI-assisted diagnostics to healthcare providers, pharmaceutical companies, and research institutions.

Specifically, Deciphex has developed two digital pathology software platforms

(1) Patholytix which enables study based pathology review for preclinical studies and clinical trials and

(2) Diagnexia a tech-enabled clinical pathology diagnostic service, delivered by our network of clinical pathologists.  

We also have strategic partnerships with Pharma/ CROs to develop state-of-the-art AI, along with its own internal AI program for Clinical diagnostics. 

As Deciphex expands our US market presence and federal healthcare program participation, were looking to hire a  senior compliance & risk leader to establish and maintain comprehensive regulatory compliance frameworks, with particular emphasis on Office of Inspector General (OIG) requirements and US healthcare regulations. 

Read more about Deciphex here and more about our incredible team on our Careers Page here 

📘 About the Role

• Deciphex is seeking a visionary Chief Compliance Officer, who will serve as a member of the Senior Leadership Team.
• You will be a strategic risk enabler, distilling complexity into simple actionable risk calls - allowing us to move at speed (operating with discipline but at a super fast scaling & innovative, scaling startup space) 
• You'll build light and scalable systems that are compliant and manage risk but wont block / hinder speed of delivery. 
• The role will involve driving the activities of Deciphex’s Compliance Team in accordance with principles of ‘compliance by design’.  
• You'll provides strategic leadership to ensure Deciphex maintains the highest standards of legal, regulatory, and ethical compliance across all business operations while supporting the company's growth objectives in highly regulated healthcare markets.
• The role will also line-manage, mentor and advocate for the existing, highly experienced Quality, Regulatory and Data Privacy teams, who have established our existing QMS and compliance landscape for our products and services.   
• You must blend strategic oversight with practical problem resolution and must be comfortable taking ownership of risk. (risk tolerance, judgement under pressure, and rapid escalation)

🎯 What you will help us achieve

As a trusted leader and independent voice, you will embody our values while engaging across the  organization.

Champion and drive Deciphex’s global regulatory vision and strategy, shaping the future of our healthcare 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
• Championing a culture of integrity and organizational resilience.
• 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.

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.

• Provide strategic oversight for global AI-based medical device compliance.
• Guiding Privacy, EU AI Act and international medical device requirements
• Supporting regulatory submissions and clinical validation, and ensuring effective post-market surveillance through the manager leading day-to-day execution.
• Provide strategic leadership and oversight for our accredited laboratory and clinical service operations - empowering 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.

• 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.
  

🔧 Required Skills and Experience

• Advanced degree in healthcare administration, compliance, or related field
• Certified in Healthcare Compliance (CHC) or Certified Compliance & Ethics Professional (CCEP) highly desirable
• Minimum 10 years progressive compliance experience in healthcare or med tech industry, with minimum 5 years in senior compliance leadership role
• 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

🔍 Desirable Skills and Experience

• Enthusiastic with genuine interest in science and technology
• Expert understanding of OIG Compliance Programs, Medicare/Medicaid regulations and reimbursement
• 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

✔️ Behavioral Indicators (critical for role success) 

• Ability to influence through concise, evidence-backed argument
  Ability to distil complexity into one or two critical risk statements
  Focus on building lightweight, scalable, non-bureaucratic systems
• Moves at real speed & can handle ambiguity when needed 
  Ability to be ab enabling governance partner with strong commercial awareness.
• Supports rapid decision making
• Builds credibility quickly with C suite, clinical, commercial, and technical teams
• Balances commercial urgency with sound judgement and proportionate controls
• Makes confident calls under uncertainty and escalates early when required
• Holds firm with senior stakeholders while maintaining constructive relationships
• Adapts seamlessly between strategic thinking and operational problem solving
• Creates a culture of accountability, transparency, and commercially minded compliance

What are the benefits of working with Deciphex? 

• 💼 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 startup environment.
• 🌴 Competitive annual leave
• 🩺 Healthcare benefits and pension with company match

Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race,  religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.

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