Regulatory / Compliance Manager

Sigma Consulting Group; Greater London; Hybride; GBP 45 000 - 55 000; Plein temps

Avantages offerts par ce poste

Meaningful equity

Impact on patient safety

Opportunity to build compliance team

Résumé du poste

A leading healthcare compliance firm is seeking a Regulatory / Compliance Manager to build and oversee compliance operations. This role requires a minimum of 4 years of relevant experience and strong knowledge of MHRA regulations. Key responsibilities include establishing compliance workflows and serving as the primary point of contact for regulatory audits. The position offers the chance to have a direct impact on patient safety and healthcare quality, along with the opportunity to design a compliance strategy for a growing AI-driven platform.

Qualifications

• Minimum of 4 years experience in regulatory affairs, compliance, or quality assurance.
• Expert knowledge of MHRA regulations and UK medical device compliance (MDR 2002).
• Strong understanding of UKCA/CE marking requirements and transition timelines.

Responsabilités

• Establish and maintain MHRA medical device distributor registration.
• Design supplier compliance verification workflows.
• Build automated compliance monitoring systems.
• Serve as primary contact for MHRA inquiries and audits.

Connaissances

Regulatory Affairs

Compliance Management

Risk Assessment

Documentation Skills

Description du poste

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

About Zenrox

Zenrox Healthcare UK is an AI-powered medical equipment marketplace, trusted by healthcare facilities across the country. Our automated compliance engine verifies MHRA and UKCA certifications in real time, ensuring all products and transactions meet NHS and CQC standards. We eliminate compliance risks for healthcare providers through robust, technology-driven regulatory safeguards.

The Opportunity

We are seeking a highly skilled Regulatory / Compliance Manager to own and shape the entire compliance function at Zenrox. In this foundational role, you will build the systems, processes, and documentation that ensure our marketplace operates in full adherence with MHRA, UKCA, NHS, and CQC requirements.

You will manage all aspects of regulatory strategy as we scale, ensuring Zenrox remains audit-ready, compliant, and trusted by healthcare organisations nationwide.

Key Responsibilities

• Establish and maintain Zenrox's MHRA medical device distributor registration and ensure ongoing compliance.
• Design and manage supplier compliance verification workflows, including checks on MHRA registration, UKCA/CE marking, insurance, and required certifications.
• Build automated compliance monitoring and documentation systems integrated with the ZenroxIQ platform.
• Maintain audit-ready documentation for all suppliers, products, and transactions.
• Continuously monitor regulatory changes (MHRA, NHS, UKCA transition timelines) and update internal processes accordingly.
• Serve as the primary point of contact for MHRA inquiries, regulatory audits, inspections, and compliance reviews.
• Develop compliance training materials and deliver sessions for internal teams and suppliers.
• Implement audit trail generation capabilities to support NHS compliance audits and CQC inspections.
• Establish and manage GDPR‑compliant data protection policies and internal processes.
• Collaborate with legal counsel on supplier agreements, terms of service, and regulatory risk mitigation.
• Support sales teams with compliance documentation, tender support, and customer assurance materials.

What You Bring

• Minimum of 4 years experience in regulatory affairs, compliance, or quality assurance.
• Expert knowledge of MHRA regulations and UK medical device compliance (MDR 2002).
• Strong understanding of UKCA/CE marking requirements and transition timelines.
• Experience with medical device classification, risk assessment, and regulatory submissions.
• Exceptional attention to detail with a structured approach to documentation and audit preparation.
• Ability to translate complex regulation into manageable operational processes.
• Strong risk management orientation with the ability to identify and resolve compliance gaps.
• Excellent written communication and documentation skills.
• Regulatory experience within medical device manufacturing, distribution, or importing.
• Experience preparing for CQC inspections or NHS compliance audits.
• Hands‑on exposure to ISO 13485 quality management systems.
• Experience in e‑commerce, marketplace, or multi‑vendor compliance environments.
• Familiarity with AI or Software‑as‑a‑Medical‑Device (SaMD) regulatory frameworks.
• Experience building compliance functions within startups or scale‑ups.

Why Join Zenrox

• Foundational regulatory role with meaningful equity.
• Opportunity to design and own compliance strategy for a fast‑growing, AI‑driven healthcare platform.
• Leverage automated tools that remove manual compliance workload.
• Direct impact on patient safety, healthcare quality, and institutional risk reduction.
• Long‑term opportunity to build and lead the compliance team.

How to Apply

Send your CV and a brief overview of your regulatory/compliance experience to:
https://www.zenroxmed.co.uk/jobs/regulatory-compliance-manager/ Email subject line:
Regulatory/Compliance Manager Application [Your Name]