3 of 3 Permanent 21 CFR Part 11 Jobs in London

platform’s next chapter - a Patient Registry solution, electronic data capture platform, and a validated ePRO library. Ship a regulatory‐grade product, considering e.g. 21 CFR Part 11 audit trails and eConsent with e‐signatures. Treat compliance as a design constraint to engineer around … ePRO/eCOA, eConsent, patient registry, or sensor‐based study platforms. Hands‐on experience shipping under GCP/ICH E6(R3), 21 CFR Part 11, and EU Annex 11, including computer system validation and audit‐ready release management. Working fluency in clinical data standards, especially ...

late-stage clinical trials. Its products operate at the intersection of several regulatory regimes, including IVDR, MDR/SaMD, ICH E6 (R3) GCP, 21 CFR Part 11, the EU AI Act, and the emerging FDA and EMA frameworks for AI in drug development. Responsibilities Lean … practice and trials. Working knowledge of computerised system validation in clinical trials, ICH E6 (GCP), GAMP 5, ISO 13485, ISO 14971, IEC 62304 and 21 CFR Part 11. Familiarity with AI-specific quality and risk frameworks: FDA AI/ML SaMD Action Plan and FDA guidance ...

Location: LiverpoolSalary: 50,000 - 60,000 (per annum)Job type: PermanentWorking pattern: Full timeIndustry: Engineering/Mechanical EngineeringCompany: HaysConsultant: Alex MellorHays office: Liverpool — Part 2nd Floor, 5 St Paul’s Square,Phone: 01512391296Email: Alex.Mellor@hays.comControl Engineer – NuclearLocation: North West Salary: Competitive, dependent on experience Sector: Nuclear/Industrial Machinery … 18th Edition and relevant BS EN standards.Experience with ATEX, hazardous-area equipment or intrinsically safe circuits would be advantageous.Knowledge of GAMP 5/FDA 21 CFR Part 11 would also be beneficial, particularly for candidates coming from pharmaceutical environments. [Hosokawa.pdf | PDF]The PersonWe're looking ...