6 of 6 Permanent 21 CFR Part 11 Jobs in London

software products. You'll be responsible for aligning information security and data protection with our mission to deliver FDA-regulated digital therapeutics. This includes leading regulatory security compliance (HIPAA, 21 CFR Part 11, FDA SaMD guidelines), proactively managing risk, and collaborating across engineering, product, compliance, and leadership teams. Location NYC, London, Ramat-Gan This role is … the opportunity to collaborate closely with our dynamic team in person. Responsibilities Design, implement, and lead Remepy's security practice and enterprise cybersecurity program Own security compliance with HIPAA, 21 CFR Part 11, FDA pre/postmarket cybersecurity guidance, and related frameworks Collaborate with Product, Engineering, and Compliance to embed security-by-design across our software More ❯

systems, HMI packages, building management systems, SCADA systems, and PC networking technology Familiarity with FDA GMPs and FDA regulations relating to biologic and drug products Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11 More ❯

driving secure, scalable DevOps practices across the organization. This includes building and automating infrastructure, championing compliance-ready CI/CD pipelines, and aligning system architecture with regulatory requirements (HIPAA, 21 CFR Part 11, FDA SaMD guidelines). You will work cross-functionally with engineering, product, compliance, and leadership teams to deliver infrastructure that meets the highest More ❯

driving secure, scalable DevOps practices across the organization. This includes building and automating infrastructure, championing compliance-ready CI/CD pipelines, and aligning system architecture with regulatory requirements (HIPAA, 21 CFR Part 11, FDA SaMD guidelines). You will work cross-functionally with engineering, product, compliance, and leadership teams to deliver infrastructure that meets the highest More ❯

system platforms desirable e.g., Siemens, Rockwell, Unicorn etc. • Experience with PLC, HMI, and SCADA an advantage. • Knowledge and familiarity with regulated industry standards, including exposure to cGMP, GAMP and 21 CFR Part 11. • Excellent communication skills and interpersonal skills. and Ability to work effectively in a fast-paced project. • Willing to work shift and in a team More ❯

system platforms desirable e.g., Siemens, Rockwell, Unicorn etc. • Experience with PLC, HMI, and SCADA an advantage. • Knowledge and familiarity with regulated industry standards, including exposure to cGMP, GAMP and 21 CFR Part 11. • Excellent communication skills and interpersonal skills. and Ability to work effectively in a fast-paced project. • Willing to work shift and in a team More ❯