Head of Compliance and Regulatory Affairs

Head of Compliance and Regulatory Affairs Up to £60,000 London Permanent Are you experienced in quality management and regulatory affairs within medical diagnostics or life sciences? Would you like to shape compliance strategy within a fast-growing UCL spin-out? The role Guilford Street Laboratories is seeking a Head of Compliance and Regulatory Affairs to oversee company certifications, regulatory clearances and international standards. You will develop and maintain our Quality Management System and Information Security Management System, manage regulatory submissions and prepare the business for audits and inspections. As the company expands, you will also build and lead an effective compliance team. The role is primarily based across our offices in King s Cross and Guilford Street, London, with monthly travel to Liverpool. Key responsibilities Maintain compliance with ISO 27001, ISO 9001, ISO 13485 and ISO 15189. Manage UKCA, CE and FDA 510(k) regulatory submissions. Oversee regulatory clearances for medical devices and services in the UK, EU and US. Maintain QMS and ISMS documents, records and supporting evidence. Conduct internal audits and manage corrective actions. Deliver QMS and ISMS training, including staff inductions. Approve and monitor vendors against company quality standards. Manage post-market surveillance alongside sales and marketing. Oversee specialist quality and regulatory consultants. Build the compliance function as the business grows. About our ..... full job details .....