Job Description
No recruitment agencies please.Company:Qureight Ltd is a Cambridge, UK-based company that accelerates clinical trial development at key decision points through data curation and Al-powered decision-making. We work with pharmaceutical companies, contract research organisations and hospitals to curate data and help the best drugs get approved: so they can be given to patients who need them the most. We are currently focused on lung and heart disease.TechnologySince 2018 we have developed an Al-powered technology stack for collaborative analysis for imaging, clinical data and Biomarkers. Our proprietary technology includes Al-based image algorithms for CT scans, Al-assisted workflows and central image read cloud-based technology. Our platform allows our partners to run Al-based data analytics on complex trial data including images, clinical data and biomarkers.Our purpose-built technology has been created by world-leading experts in healthcare data, that is fast, efficient and Al-guided central read image workflows for clinical trials, along with the capability of Al-powered quantitive imaging analysis of CT scans including quantification of lung volumes, airways, pulmonary vessels and fibrosis.In 2022 Qureight gained certification of ISO13485, whilst introducing a Document Management System. We are now looking to recruit a temporary person, starting in September 2024 (12 months cover), to work in a hybrid role and reside either in Cambridge (UK) or the surrounding area to lead the company's Quality and regulatory requirements, with the future expectations to gain CE marking and FDA.The Quality Lead is the management responsible for the effectiveness of the company quality management system to meet ISO 13485 requirements and the Person Responsible for Regulatory Compliance (PRRC) in accordance with EU MDR 2017/745 Annex 15 regulations. They will be primarily responsible for all quality and regulatory activities within the organisation, whilst supporting project teams to ensure that all new and existing projects have been established and met to meet the client's expectations.Key experience: Lead Auditor or Internal Auditor of ISO13485 along with FDA introduction and communication. Desirable experience within a SaMD business is a bonus.RequirementsMinimum RequirementsUK applicants OnlyCambridge (UK) reliably commute or plan to relocate before starting work (preferred)Full right to work in the UK without restriction, time limit, or sponsorshipAt least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices (should the employee meet the educational requirements as set by MDR 2017|745 Annex 15)two years of professional experience in regulatory affairs or in quality management systems relating to medical devices.Lead or Internal auditor trained in ISO13485Desirable ExperienceSoftware as a Medical Device is advantageous.Knowledge of FDA approval process is advantageous.Roles and Responsibilities:Person Responsible for Regulatory Compliance (PRRC) in accordance with EU MDR2017/745 Annex 15:The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before a device is released.The technical documentation and the EU declaration of conformity are drawn up and kept up to date.The post-market surveillance obligations are complied with in accordance with Article 10(10).The reporting obligations referred to in Articles 87 to 91 are fulfilled.In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.Management Representative in accordance with ISO13485 Clause 5: Management Responsibility:Ensuring that processes needed for the quality management system are documented.Reporting to top management on the effectiveness of the quality management system and any need for improvement.Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organisation.BenefitsFull timeFlexible working hoursHybrid workingContributory pension scheme25 days annual leave, plus bank holidays (Pro-rata)Beautiful office in the heart of Cambridge (10 min from station) as well as opportunity to use our London shared space officesOpportunities for personal development and academic collaborations in a vibrant and fast-acting companyOpportunities for personal and professional development as we rapidly scale the companyThe chance to join a friendly, motivated group of people on a mission for universal good in healthcareQureight Ltd
Apply
Go Back