Regulatory / Compliance Manager

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