Quality & Compliance Manager

Job Description:

Senior Regualtory Manager

Role Overview

We are seeking a hands-on Senior regulatory 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

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

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

• Maintain accurate and up-to-date compliance documentation

Quality & Environmental Management Systems

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

• Manage and support the ISO 14001 Environmental Management System

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

Testing & Standards

• Create and manage product testing schedules

• Ensure products meet internal specifications and external regulatory requirements

• Coordinate testing activities and manage records of results and approvals

Regulatory & Certification Readiness

• Lead the scoping and preparation activities for ISO 13485 certification

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

• Monitor regulatory changes and assess impact on products and systems

Skills & Experience

Essential:

• Proven experience in a Quality, Compliance, or Regulatory role

• Strong working knowledge of UKCA and CE marking

• Experience working with ISO 9001 and ISO 14001 management systems

• Experience managing technical documentation and product compliance files

• Confident working with regulatory standards and audits

Desirable:

• Experience with MHRA and FDA regulations

• Experience preparing for or working towards ISO 13485

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

Personal Attributes

• Hands-on and detail-oriented approach

• Strong organisational and documentation skills

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

• Clear communicator with internal and external stakeholders

• 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.