Quality & Compliance Manager

Job Description: Quality & Compliance Manager

Role Overview

We are seeking a hands-on Quality & Compliance Manager to take ownership of product compliance, quality systems, and regulatory documentation across a growing product portfolio. This role is responsible for managing technical files, ensuring compliance with UK, EU, and US regulations, and maintaining effective quality and environmental management systems.

This is a key role within the business, offering the opportunity to lead the compliance function and play a central part in preparing the organisation for ISO 13485 certification.

Key Responsibilities

Product Compliance & Documentation

Own and manage Product Technical Files across the full product range

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Ensure products meet UKCA, CE, MHRA, FDA, and applicable US labelling and regulatory requirements

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Create, review, and maintain Instructions for Use (IFUs) in line with regulatory standards

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Maintain accurate and up-to-date compliance documentation

Quality & Environmental Management Systems

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Operate, maintain, and continuously improve the ISO 9001 Quality Management System

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Manage and support the ISO 14001 Environmental Management System

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Ensure quality processes remain effective, compliant, and audit-ready

Testing & Standards

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Create and manage product testing schedules

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Ensure products meet internal specifications and external regulatory requirements

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Coordinate testing activities and manage records of results and approvals

Regulatory & Certification Readiness

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Lead the scoping and preparation activities for ISO 13485 certification

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Identify gaps, implement improvements, and support readiness for external audits

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Monitor regulatory changes and assess impact on products and systems

Skills & Experience

Essential:

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Proven experience in a Quality, Compliance, or Regulatory role

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Strong working knowledge of UKCA and CE marking

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Experience working with ISO 9001 and ISO 14001 management systems

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Experience managing technical documentation and product compliance files

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Confident working with regulatory standards and audits

Desirable:

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Experience with MHRA and FDA regulations

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Experience preparing for or working towards ISO 13485

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Background in medical devices, healthcare products, or other regulated manufacturing environments

Personal Attributes

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Hands-on and detail-oriented approach

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Strong organisational and documentation skills

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Able to work independently and take full ownership of the compliance function

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Clear communicator with internal and external stakeholders

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Comfortable working in a growing, evolving business environment

Employment Details & Benefits

Salary: £50,000 – £65,000 (dependent on experience)

Bonus: Profit share scheme

Holiday: 23 days annual leave plus 8 bank holidays

Additional leave: Bonus birthday holiday

Benefits: Optional private healthcare scheme

Working pattern: Full-time, 8:00am – 4:30pm

Location: Hybrid

Why Apply?

This is an opportunity to take ownership of compliance within a growing business, shape the next phase of quality and regulatory systems, and play a pivotal role in achieving future certification milestones