Head of Compliance and Regulatory Affairs in EC1

Job DescriptionHead 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 company Guilford Street Laboratories is a fast-growing spin-out from University College London. We develop and deliver innovative products and services within proteomics diagnostics, with the potential to transform how diseases are identified and managed. The Benefits: * Contributory Pension scheme – auto enrolment * Life Insurance- auto enrolment * Optional Private Health Insurance - after qualifying period The person You will need: * A degree or equivalent qualification in life sciences, quality management or a related subject. * At least three years’ experience in compliance, QMS or regulatory affairs, ideally within proteomics, IVD or SaMD. * An Internal Auditor qualification in ISO 13485, ISO 9001 or ISO 27001. * Knowledge of medical device regulations and regulatory approval processes. * Experience working with external stakeholders and consultants. * Strong organisational, record-keeping and communication skills. * Permanent right to work in the UK. * Further Lead Auditor training across relevant ISO standards and GCP would be welcomed. What’s next? If you are ready to take ownership of compliance and regulatory affairs within a growing diagnostics company, apply today