3 Mhra Regulations Jobs

As the Senior Integration Manager for the UK (Remote) at Diagnexia, a subsidiary of Deciphex, you will play a crucial role in spearheading complex integration projects for histopathology laboratories across the United Kingdom. Your responsibilities will include translating UK-specific operational and regulatory needs into scalable IT solutions, overseeing the integration of various systems such as LIMS/LIS, Digital Pathology PACS, and digital slide imaging, and ensuring seamless connectivity, compliance with NHS standards, and alignment with strategic digital pathology initiatives for UK clients. Your role will involve conducting detailed assessments of UK laboratory workflows, defining integration roadmaps aligned with UK healthcare priorities, designing interoperable solutions based on HL7, DICOM WSI, and FHIR standards, and collaborating with UK-based cybersecurity and Information Governance teams to embed security-by-design practices. You will be responsible for leading end-to-end delivery of UK integration projects, managing timelines, budgets, and quality in accordance with NHS procurement frameworks and PRINCE2 methodology. Additionally, you will engage with stakeholders such as UK pathology directors, NHS IT leads, and private lab executives to gather requirements, provide technical mentorship to UK-based team members, and identify and mitigate UK regulatory and operational risks. To excel in this role, you should possess a Bachelor's or Master's degree in Computer Science, Biomedical Engineering, or a related field, along with a minimum of 10 years of experience in IT architecture and systems integration within UK healthcare or laboratory environments. Strong knowledge of UK healthcare regulations, relevant certifications such as PRINCE2 Practitioner or PMP, and core competencies including advanced problem-solving skills and exceptional communication abilities are essential. Working at Diagnexia offers numerous benefits, including a competitive salary with performance-based annual increments, healthcare benefits, competitive annual leave, and the opportunity to contribute to better patient outcomes in a dynamic and collaborative environment. Join us to work on exciting and challenging projects, receive regular performance feedback, and enjoy significant career growth opportunities within a supportive and multicultural team.,

As a Clinical Quality Assurance Manager at Sarah Cannon Research Institute (SCRI) in London, you will play a crucial role in supporting the delivery of high-quality clinical trials within cancer research. Your responsibilities will include ensuring best practices, developing and shaping the QA framework, enhancing SOPs, and ensuring alignment with regulatory requirements and industry standards, particularly with a strong knowledge of GCP. You will be instrumental in supporting process improvement initiatives, ensuring that the site operates within approved study protocols and regulatory frameworks. Additionally, you will provide guidance, training, and support to the research team, lead routine audits internally and externally, and support sponsor and regulatory inspections. To excel in this role, you must possess a Bachelor's or Master's degree in nursing, pharmacy, or a related scientific field. A solid understanding of GCP, MHRA Regulations, GMP, Good Documentation Practices (GDP), and Pharmacovigilance (PV) is essential. Moreover, you should have sound knowledge of UK Clinical Trials Regulations, EU Directive (2001/20/EC), ICHGCP R2, and other relevant guidelines pertaining to clinical trials of investigational medicinal products. Experience in leading internal and/or external audits in alignment with GCP regulations and standards will be beneficial. At HCA UK, we value our employees and strive to provide exceptional care for both our patients and our staff. With over 50 years of experience, HCA is a leading healthcare provider globally. In the UK, we are among the largest providers of privately funded healthcare and have invested significantly in the latest treatments, technology, and facilities. Joining our team means access to unparalleled opportunities for career advancement, internal and external training, and a supportive work environment that prioritizes your mental and physical well-being. As a Clinical Quality Assurance Manager at HCA UK, you will enjoy a range of benefits, including private healthcare insurance, a generous pension contribution, holiday leave that increases with service, and discounts with major retailers. We believe in fostering a culture that celebrates diversity, values individual experiences, and promotes kindness, compassion, honesty, integrity, fairness, loyalty, respect, and dignity among our team members. HCA UK is committed to the care and improvement of human life, for both patients and colleagues. We are dedicated to providing a supportive and inclusive workplace where everyone can thrive. We are a Disability Confident committed organization and are open to discussing flexible working arrangements and offering reasonable adjustments throughout the recruitment process and in the workplace to accommodate individual needs.,

As the Senior Integration Manager for the UK at Diagnexia, a subsidiary of Deciphex, you will play a crucial role in spearheading complex integration projects for histopathology laboratories across the United Kingdom. Your responsibilities will include translating UK-specific operational and regulatory needs into scalable IT solutions, connecting various systems such as LIMS/LIS, Digital Pathology PACS, and digital slide imaging platforms. You will serve as the primary technical authority for UK clients, ensuring seamless connectivity, compliance with NHS standards, and alignment with strategic digital pathology initiatives. Your role will involve conducting detailed assessments of UK laboratory workflows, defining integration roadmaps in alignment with UK healthcare priorities, and designing interoperable solutions tailored for UK regulatory requirements. You will be responsible for architecting and deploying integration frameworks, collaborating with cybersecurity and Information Governance teams to embed security-by-design practices, and leading end-to-end delivery of UK integration projects within NHS procurement frameworks. Additionally, you will engage with various stakeholders including UK pathology directors, NHS IT leads, and private lab executives to gather requirements, facilitate technical forums, and provide technical mentorship to team members on integration best practices. Your role will also involve identifying and mitigating UK regulatory and operational risks, monitoring integration performance, and staying updated on UK digital pathology trends. In terms of qualifications and experience, we are looking for candidates with a Bachelor's or Master's degree in Computer Science, Biomedical Engineering, or a related field, along with a minimum of 10 years of experience in IT architecture and systems integration within UK healthcare or laboratory environments. Strong knowledge of UK healthcare regulations, relevant certifications such as PRINCE2 Practitioner or PMP, and core competencies including solution architect mindset and exceptional communication skills are essential for this role. Working at Diagnexia offers competitive salary with performance-based annual increments, healthcare benefits, competitive annual leave, and a sense of purpose by contributing to better patient outcomes. You will have the opportunity to work alongside a high-performing team in a hyper-growth startup environment, work on exciting projects, receive regular performance feedback, and access significant career growth opportunities. Join our collaborative and supportive multicultural team to make a difference in the emerging Digital Pathology field.,