REGULATORY / COMPLIANCE MANAGER

Zenrox Healthcare Ltd; Greater London; Hybrid; GBP 45,000 - 55,000; Full time

Benefits offered by this job

Equity stake

Hybrid work model

Job summary

Zenrox Healthcare Ltd in London is hiring a Regulatory & Compliance Lead to own MHRA/UKCA strategy for our AI-powered medical equipment marketplace. You will build processes to verify supplier compliance, maintain audit-ready documentation, and ensure NHS and CQC standards as we scale.

This foundational role offers substantial equity and the chance to shape how we automate compliance, monitor regulatory changes, and collaborate with legal and product teams to protect patient safety.

Qualifications

• 4+ years experience in regulatory affairs, compliance, or quality assurance.
• Deep knowledge of MHRA regulations and medical device compliance (MDR 2002).
• Understanding of UKCA/CE marking requirements and transition timelines.
• Experience with medical device classification and regulatory submissions.
• Strong attention to detail with systematic approach to documentation.
• Ability to translate complex regulations into practical operational processes.
• Risk management mindset with proactive problem identification.
• Excellent written communication for regulatory documentation.

Responsibilities

• Establish MHRA distributor registration and compliance.
• Design and implement supplier compliance verification processes (MHRA registration, UKCA/CE marking, insurance, certifications).
• Build automated compliance monitoring systems integrated with ZenroxIQ platform.
• Maintain audit-ready documentation for all suppliers and transactions.
• Monitor regulatory changes and update internal processes accordingly.
• Serve as primary contact for MHRA, regulatory audits, and compliance inquiries.
• Develop compliance training materials for internal teams and suppliers.
• Create audit trail generation capabilities for NHS compliance audits and CQC inspections.
• Establish data protection and GDPR compliance processes.
• Work with legal counsel on terms of service, supplier agreements, and risk mitigation.
• Support sales team with compliance documentation and customer assurance materials.

Skills

Regulatory affairs

Compliance

Quality assurance

Documentation & audits

Risk management

UK MHRA regulations

GDPR compliance

Regulatory submissions

Job description

Location: London (Hybrid) or Remote (UK-based)

Salary: £50,000 + equity

About Zenrox

Zenrox Healthcare UK operates an AI-powered medical equipment marketplace. Our automated compliance engine instantly verifies MHRA/UKCA certifications and ensures every transaction meets NHS and CQC standards—eliminating compliance risk for our healthcare facility customers.

The Opportunity

Own compliance and regulatory strategy for Zenrox. You'll build the processes that verify supplier compliance, maintain our audit-ready documentation, and ensure we meet all MHRA, UKCA, and NHS requirements as we scale.

What You'll Do

• Establish and maintain MHRA medical device distributor registration and compliance
• Design and implement supplier compliance verification processes (MHRA registration, UKCA/CE marking, insurance, certifications)
• Build automated compliance monitoring systems integrated with ZenroxIQ platform
• Maintain audit-ready documentation for all suppliers and transactions
• Monitor regulatory changes and update internal processes accordingly
• Serve as primary contact for MHRA, regulatory audits, and compliance inquiries
• Develop compliance training materials for internal teams and suppliers
• Create audit trail generation capabilities for NHS compliance audits and CQC inspections
• Establish data protection and GDPR compliance processes
• Work with legal counsel on terms of service, supplier agreements, and risk mitigation
• Support sales team with compliance documentation and customer assurance materials

What You Bring

• 4+ years experience in regulatory affairs, compliance, or quality assurance
• Deep knowledge of MHRA regulations and medical device compliance (MDR 2002)
• Understanding of UKCA/CE marking requirements and transition timelines
• Experience with medical device classification and regulatory submissions
• Strong attention to detail with systematic approach to documentation
• Ability to translate complex regulations into practical operational processes
• Risk management mindset with proactive problem identification
• Excellent written communication for regulatory documentation

Ideal Background

• Medical device manufacturer, distributor, or importer regulatory experience
• NHS compliance, CQC inspection preparation, or healthcare quality assurance
• ISO 13485 quality management system implementation
• Experience with compliance in marketplace, e-commerce, or multi-vendor platforms
• Familiarity with AI/software as medical device (SaMD) regulations
• Previous startup or scale-up experience building compliance function

Why Join Zenrox

• Foundational compliance role with significant equity stake
• Shape compliance strategy for innovative AI-powered healthcare platform
• Work with automated systems that eliminate manual compliance burden
• Direct impact on patient safety and healthcare facility risk reduction
• Opportunity to build and eventually lead compliance team