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Open nowFirst seen 4 days ago

Regulatory / Compliance Manager

Sigma Consulting Group570 open roles

Pay
£50,000 a year
Where
London, United Kingdom
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Your applicationOpen nowRegulatory / Compliance ManagerSigma Consulting Group · London, United Kingdom

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This job: first seen 4 days ago

The posting

Regulatory / Compliance Manager

Location: London, United Kingdom (Hybrid) or Remote (UK-Based) Employment Type: Full-Time Department: Risk & Compliance Compensation: £50,000 + Equity

About Zenrox

Zenrox Healthcare UK is an AI-powered medical equipment marketplace trusted by healthcare providers across the United Kingdom. Our platform, ZenroxIQ, integrates automated compliance intelligence to ensure that all listed products meet MHRA, UKCA, NHS, and CQC regulatory standards.

Through real-time verification and structured compliance workflows, we eliminate regulatory risk and ensure that healthcare organisations can procure safely, efficiently, and with full confidence.

The Opportunity

We are seeking a highly experienced Regulatory / Compliance Manager to establish and lead the compliance function at Zenrox.

In this foundational role, you will design and implement the regulatory frameworks, systems, and governance structures that ensure full compliance across all marketplace activities. As Zenrox scales, you will play a critical role in maintaining audit readiness, regulatory integrity, and institutional trust across the UK healthcare ecosystem.

Key Responsibilities

Regulatory Strategy & Governance

  • Establish and maintain Zenrox's MHRA medical device distributor registration
  • Define and oversee the company's overall regulatory compliance framework
  • Ensure ongoing adherence to MHRA, UKCA, NHS, and CQC requirements

Supplier & Product Compliance

  • Design and manage supplier onboarding compliance workflows
  • Verify supplier documentation including MHRA registration, UKCA/CE marking, insurance, and certifications
  • Maintain accurate and audit-ready compliance records for all suppliers, products, and transactions

Compliance Systems & Automation

  • Develop and implement automated compliance monitoring systems within the ZenroxIQ platform
  • Build structured documentation processes that support scalability and audit readiness
  • Ensure continuous improvement of compliance workflows through technology and automation

Regulatory Monitoring & Risk Management

  • Monitor regulatory developments across MHRA, NHS procurement standards, and UKCA transition timelines
  • Assess regulatory impact and update internal policies and procedures accordingly
  • Identify and mitigate compliance risks across the marketplace ecosystem

Audit, Inspection & External Engagement

  • Serve as the primary point of contact for MHRA audits, inspections, and regulatory inquiries
  • Ensure full audit readiness for NHS and CQC inspections
  • Maintain structured audit trails and compliance reporting mechanisms

Training & Internal Enablement

  • Develop compliance training materials for internal teams and external suppliers
  • Conduct training sessions to ensure organisation-wide regulatory awareness
  • Support embedding of compliance culture across all departments

Data Protection & Legal Collaboration

  • Implement and maintain GDPR-compliant data protection policies and procedures
  • Collaborate with legal counsel on supplier agreements, terms of service, and regulatory risk mitigation strategies
  • Support legal and commercial teams with compliance documentation for tenders and contracts

Requirements

  • Minimum of 4+ years' experience in regulatory affairs, compliance, or quality assurance
  • Strong working knowledge of MHRA regulations and UK medical device compliance (MDR 2002)
  • Understanding of UKCA/CE marking requirements and regulatory transition frameworks
  • Experience in medical device classification, risk assessment, and compliance submissions
  • Strong documentation, reporting, and audit preparation capabilities
  • Excellent attention to detail with a structured and process-driven mindset
  • Ability to interpret complex regulations and translate them into operational processes
  • Strong risk assessment and problem-solving capabilities
  • Excellent written communication and regulatory documentation skills

Preferred / Advantageous Experience

  • Experience in medical device manufacturing, distribution, or importing
  • Prior exposure to CQC inspections or NHS compliance audits
  • Knowledge of ISO 13485 Quality Management Systems
  • Experience in marketplace, e-commerce, or multi-vendor compliance environments
  • Familiarity with AI-driven healthcare systems or Software-as-a-Medical-Device (SaMD) frameworks
  • Experience building or scaling compliance functions in startups or high-growth organisations

Why Join Zenrox

  • Foundational compliance leadership role with equity participation and long-term growth potential
  • Opportunity to design and own the regulatory framework for an AI-driven healthcare platform
  • Work with automated systems that significantly reduce manual compliance workload
  • Direct impact on patient safety, regulatory integrity, and healthcare quality in the UK
  • Opportunity to build and lead the compliance and regulatory team as the company scales

How to Apply

Interested candidates should submit their CV and a brief overview of their regulatory/compliance experience via: https://www.zenroxmed.co.uk/jobs/regulatory-compliance-manager/

Email Subject Line: Regulatory / Compliance Manager Application

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