76 to 100 of 101 21 CFR Part 11 Jobs in the UK

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

building automated quality checks, validation frameworks, or similar systems. Nice-to-haves Knowledge of relevant standards and compliance frameworks (e.g. ISO 27001, SOC 2, ISO 9001, GAMP 5, FDA 21 CFR Part 11, ALCOA+, BS 10008). Experience with regulated environments (GMP, HIPAA, etc.). Understanding of hardware-software integration. Experience with containerisation and orchestration (Docker … options - Lunch covered daily in-office with team - Collaborative team environment with very high potential to learn new skills - 32 days holiday (bank holidays, end-of-year closure, and 21 days discretionary PTO) - Pension - Awesome colleagues and an office in the Imperial College Innovation hub in White City, where you'll be based We're building a team that 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 ❯

protocols Define and implement computing infrastructure, including server architecture, virtualization, and cybersecurity Manage the full project lifecycle from requirements gathering through commissioning and validation Ensure compliance with GAMP5, cGMP, 21 CFR Part 11, and other regulatory standards Lead Factory and Site Acceptance Testing (FAT/SAT) Mentor junior engineers and collaborate with cross-functional teams Travel More ❯

rapid change and stability in mind. Building automated quality checks and validation frameworks. Nice-to-haves Knowledge of standards like ISO 27001, SOC 2, ISO 9001, GAMP 5, FDA 21 CFR Part 11, ALCOA+. Experience in regulated environments (GMP, HIPAA). Hardware-software integration understanding. Experience with Docker, Kubernetes. Python skills for tooling or data processing. More ❯

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 ❯

and standards for all applicable markets, including but not limited to: Hazardous Chemicals: UK & EU REACH, RoHS, California Proposition 65, AB1200 Food Contact Materials: EU 10/2011, FDA 21 CFR 175-178 Electrical & Electronic Products: Low Voltage Directive (2014/35/EU), EMC Directive (2014/30/EU), Battery Directive (2006/66/EC More ❯

in a highly regulated industry, within quality or software development functions, with ownership of software development quality assurance Experience working with BS EN 62304, ISO 14971, ISO 13485, FDA (21 CFR Part 820, 21 CFR Part 11), UK & EU regulations Experience in the application of risk-based methodologies in the oversight of product More ❯