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Regulatory / Compliance Manager

Sigma Consulting Group -
London

Quick apply

Job details

Full-time
£50,000 a month

Qualifications

Quality management
Quality assurance
Contracts
AI
Communication skills

Full job description

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

Quick apply

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Regulatory / Compliance Manager

About Zenrox

The Opportunity

Key Responsibilities

Regulatory Strategy & Governance

Supplier & Product Compliance

Compliance Systems & Automation

Regulatory Monitoring & Risk Management

Audit, Inspection & External Engagement

Training & Internal Enablement

Data Protection & Legal Collaboration

Requirements

Preferred / Advantageous Experience

Why Join Zenrox

How to Apply