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 and 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 and 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 and 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 and ..... full job details .....