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 * 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