5 of 5 Remote 21 CFR Part 11 Jobs in the UK

about Convatec, please visit Change is everywhere at Convatec. It's transforming our business, and helping us improve millions of lives. And we're nowhere near finished. Across every part of our business, we're pushing for better. Join us on our journey to as a System Owner/Technical Lead LIMS, and you'll do the same. Position … efficient, and well-documented LIMS configurations and scripts, following best practices and compliance standards. Participate in system reviews and validation activities to ensure system quality, regulatory compliance (e.g., GxP , 21 CFR Part 11), and data integrity. Troubleshoot, debug, and upgrade existing LIMS systems to ensure optimal laboratory operations and minimal downtime. Contribute to the full system … systems. Proficient in system configuration, scripting, and integration with laboratory instruments and enterprise systems (e.g., ERP). Strong understanding of laboratory processes, data management, and regulatory requirements (e.g., GxP , 21 CFR Part 11). Experience with software development methodologies (e.g., Agile, Scrum) and system validation practices. Familiarity with database technologies (e.g., SQL) and web services (e.g. More ❯

consistency across regulatory processes. 10+ years of experience in software lifecycle management and validation, with emphasis on pharma or biotech compliance. Solid knowledge of EU regulatory frameworks (e.g., GxP, 21 CFR Part 11, Annex 11). Experience preparing for and navigating ISO, SOC, and other third-party compliance audits. Strong documentation, project management, and cross More ❯

of successfully selling and overseeing complex and small-scale projects alike. Experience in technology implementation and migration projects within the life sciences industry (regulatory, quality, clinical) with regulated software (21 CFR Part 11, EU Annex 11). Proficiency in CRM solutions (e.g., Dynamics 365, Salesforce). Knowledge of project management methodologies (e.g., Agile, Waterfall) and More ❯

technical training will be provided. Proven experience in leading complex MES projects from concept to deployment. Knowledge and understanding of Pharma and Biotech industry & processes. Familiarity with GMP, FDA 21 CFR Part 11, GAMP5, and other relevant regulatory requirements. Excellent problem-solving, communication, and interpersonal skills. Ability to travel as required to client sites. What We More ❯

About the Role We're hiring a Pre-Sales Technical Consultantto join a dynamic, mission-driven team transforming the way clinical trials are run. As part of a fast-growing healthtech startup, you'll play a key role in supporting commercial growth by bridging the gap between client needs and product capability. You'll work closely with both the … SaaS, cloud, or digital health. Strong understanding of enterprise sales cycles and client engagement across regulated industries. Clinical trial tech knowledge and familiarity with sector-specific standards (e.g. GCP, 21 CFR Part 11, GDPR) is a major plus. Excellent communication skills with the ability to present technical topics to both technical and non-technical audiences. Comfortable More ❯