Head of Computerized Systems Quality Assurance & Validation
- Hiring Organisation
- Jobleads-UK
- Location
- Greater London, England, United Kingdom
/or utilised by IXICO. This role supports the drafting, review & approval of software development and validation policies and procedures, ensuring best practice for ‘security & privacy by design’ principles and in compliance with current GCP, FDA 21 CFR Part 11, EU Annex 11, GAMP, FDA QSR Part 820 (QMSR … stages of the computerized systems lifecycle, including software as a Medical Device (SaMD), AI as a Medical Device (AIaMD) validation and operation including information privacy and security requirements. Review and approve computerized system risk assessments (including as per ISO 14971& AI standards) and categorisation of software per regulatory ...