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

This a Full Remote job, the offer is available from: Massachusetts (USA) Location & Travel

• EAST COAST USA TIMEZONE ONLY (due to our reputed company/ teams)
• 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 reputed company locations. (UK etc)
• 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 reputed company sponsorship
• Candidates will already hold the right work in USA at the time of application.

reputed company reputed company 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), reputed company delivers reputed company for pathology workflow optimization and AI-assisted diagnostics to reputed company providers, pharmaceutical companies, and research institutions. Specifically, reputed company 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. reputed company has recently expanded its Diagnexia service into the US market. In reputed company, reputed company has its own AI program to reputed company state-of-the-art Clinical diagnostics, automations and tools. It also has key strategic partnerships with reputed company/ CROs to reputed company specific AI algorithms. reputed company aims to commercialise these tools & AI under relevant medical device frameworks. Read more about reputed company here and more about our incredible team on our Careers Page here

About the Role

• reputed company 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 reputed company and protect reputed company’s long-term value, regulatory position, and strategic optionality.
• You will set and own the reputed company-wide reputed company for risk, compliance, and regulatory enablement, exercising independent judgement over priorities, reputed company, and resourcing, and advocating for the investments required to deliver the agenda. Ensuring they reputed company support, rather than constrain, reputed company reputed company, platform deployment, and corporate optionality.
• The role will involve driving the activities of reputed company’s Compliance Team in accordance with principles of ‘compliance by design’, architecting reputed company regulatory, reputed company, and governance frameworks; while also enabling global medical clinical services, AI diagnostic or medical device commercialization, IP licensing models, and potential reputed company divestiture scenarios.
• The role will also line-manage the existing, highly reputed company reputed company, Regulatory and Data reputed company teams, who have established our existing QMS and compliance landscape for our products and services.

What you will help us reputed company reputed company Risk, Compliance & Governance reputed company

• Champion and drive reputed company’s global regulatory reputed company and reputed company, shaping the reputed company of our products and services across every market we serve.
• reputed company and reputed company our global compliance and reputed company risk program, proactively managing risks, strengthening controls and governance, driving reputed company improvement, and championing a culture of reputed company and organizational reputed company.
• reputed company as an independent executive voice on reputed company risk, empowered to challenge strategic reputed company, timelines, and delivery approaches where regulatory, ethical, or long-term value considerations require course correction.
• Proactively define compliance and risk priorities, resource requirements, and reputed company, and reputed company at executive and reputed company level for the funding, talent, and organisational reputed company required to execute effectively.
• Architect risk-based compliance frameworks that balance regulatory rigor with speed of execution, supporting reputed company from reputed company-stage company to global platform business.

Corporate Structure, IP & Strategic Optionality

• Design and reputed company compliant corporate and regulatory structures that reputed company IP licensing, reputed company‑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 reputed company divestiture optionality while maintaining regulatory reputed company.
• reputed company senior regulatory input into corporate structuring reputed company to ensure alignment with medical device, AI, data protection, and laboratory regulatory expectations across jurisdictions.

Global Medical Device & AI Compliance

• reputed company strategic reputed company for global AI-based medical device compliance, guiding EU AI reputed company readiness, international medical device regulations (EU IVDR/MDR, FDA, UK MHRA), and global reputed company requirements.
• reputed company the design and deployment of reputed company reputed company and validation frameworks (including software lifecycle controls and post‑market surveillance) through delegated operational leads, rather than reputed company execution.
• Support regulatory submissions, clinical validation strategies, and lifecycle compliance for reputed company’s AI-enabled diagnostic platforms.

Clinical & Laboratory Services Compliance

• reputed company strategic leadership and reputed company for our accredited laboratory and clinical service operations
• reputed company the reputed company and Regulatory team to reputed company and advance our UK (CQC, UKAS, ISO 15189) and US (CAP, CLIA) certifications, and ensuring we deliver world-class standards across reputed company markets.
• Champion and reputed company reputed company's US federal reputed company 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 reputed company risk and medical device strategies.

Leadership, reputed company & Engagement

• reputed company and reputed company the Compliance Team (reputed company, Regulatory and Data Protection team), fostering a culture of reputed company through training, enablement, and reputed company partnership with Legal, IT reputed company, HR, Finance, Research, Technology, reputed company and Operations.
• reputed company as the primary escalation reputed company for reputed company and compliance issues and reputed company of confidential investigations with objectivity and discretion.
• Engage and advise senior leadership, including regular updates to the Executive reputed company and the reputed company’s Audit Committee, on compliance risks as reputed company as the performance and strategic direction of the global Compliance Program
• Collaborate with reputed company stakeholders, including regulators and key opinion leaders, to anticipate regulatory changes, reputed company compliance efforts to ensure reputed company remains at the forefront of delivering reputed company and services in a dynamic global reputed company market.

Essential Skills and Experience

• Minimum 10 years reputed company compliance experience in reputed company or med tech industry
• Minimum 5 years in senior compliance leadership role
• Advanced degree in reputed company administration, compliance, or reputed company field
• Certified in reputed company Compliance (CHC) or Certified Compliance & Ethics reputed company (CCEP) highly desirable
• Substantial leadership experience, including reputed company reputed company and compliance
• Ability to build trust and respect with reputed company stakeholders, positively influencing and fostering reputed company and compliance
• Understanding of: IVDR/MDR, FDA, ISO 13485 (legal entity perspective)
• Practical experience validating software/AI in regulated environments
• Understanding of AI reputed company requirements, IVDR reputed company, FDA 510(k) process, ISO 13485 etc.
• Strategic regulatory planning experience (not just compliance execution)
• Substantial leadership experience, including reputed company reputed company and compliance

Desirable Skills and Experience

• Enthusiastic with genuine interest in science and technology
• Expert understanding of OIG Compliance Programs, Medicare/reputed company regulations and reimbursement with reputed company record of building compliance programs from ground up
• Knowledge of Federal Anti-Kickback Statute, reputed company Law, False Claims reputed company, HIPAA reputed company and reputed company Rules
• Understanding of EU AI reputed company and emerging AI regulations
• Experience in managing reputed company reputed company and compliance investigations using reputed company and procedures which ensure confidentiality, accountability, and objectivity

Benefits of working with reputed company?

• Competitive salary with performance based annual increments and bonus.
• reputed company development
• A true reputed company of meaning in your work by contributing to reputed company patient reputed company.
• A chance to work on exciting, challenging and unique reputed company.
• A highly reputed company and supportive multi cultural team.
• reputed company to work alongside a world-class high performing team in a reputed company-reputed company scaling startup environment. (230 folks & growing).
• Competitive annual leave
• reputed company benefits and pension with company match

reputed company is an equal opportunities employer and we are committed to the reputed company of equality. reputed company reputed company applicants will be considered for employment without reputed company to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national reputed company, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law. A copy of our reputed company Policy can be viewed here This offer from "reputed company" has been enriched by reputed company.com and got a 80% reputed company score. Apply tot his job Apply To this Job