Quality and Compliance Manager

March 7

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uMed

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uMed is a company that specializes in building consented patient cohorts to accelerate research and generate insights that improve patient outcomes. Their ACCESS Research Platform is embedded across a global network of healthcare institutions, allowing researchers to access custom patient data from remote electronic health records, clinical outcomes, and patient-generated data. uMed collaborates with healthcare providers, life science researchers, and companies to address evidence gaps in research, improve treatment development, and make research more accessible. Their platform supports evidence collection and helps answer new research questions through deeply characterized patient data, ensuring privacy and transparency for all stakeholders involved.

11 - 50 employees

⚕️ Healthcare Insurance

🧬 Biotechnology

🔬 Science

💰 $4.8M Seed Round on 2020-12

📋 Description

• What is uMed? • The process of conducting clinical research is incredibly expensive and time-consuming, limiting our efforts to find answers to the world’s most important medical challenges. • uMed is a clinical research network fit for the 21st century, underpinned by cutting edge technology that connects patients, electronic health data and research groups across the world. • Our rapidly growing network covers over 350 GP sites in the UK representing over 3,500,000 patients well as a network of US healthcare providers representing a further 3 million patients. • uMed was founded by an NHS doctor and is backed by UK and US venture capital. • The role: • uMed is looking for an experienced Quality and Compliance Manager to join our fast growing team. • The Quality and Compliance Manager will maintain our quality manual and quality system, oversee ISO compliance, coordinate and/or perform external and internal audits. • The role also involves ensuring compliance with healthcare data regulations (e.g., HIPAA, GDPR, MDR). • You should have at least 5 years of experience managing quality and compliance in a healthcare or life science organisation. • You will play a key role with overall responsibility for all aspects of quality and compliance in a cutting edge health technology company that is creating a huge impact for patients and society by accelerating medical research.

🎯 Requirements

• Minimum 5 years of experience in quality and compliance, preferably in a MedTech, healthcare, or similarly regulated industry. • Proven expertise with healthcare quality and compliance frameworks. • Strong ability to prioritize and manage a busy workload in a fast-paced environment. • In-depth understanding of the regulatory and governance challenges faced by health tech SMEs. • Familiarity with key standards and regulations, including ISO 27001, HIPAA, GDPR, Cyber Essentials Plus, and the DSP Toolkit. • Practical experience managing and maintaining ISO-compliant products with effective operational governance processes. • Excellent problem-solving, analytical, and communication skills. • Collaborative mindset with the ability to influence and engage cross-functional teams.