3 Regulatory Compliance Jobs in Cardiff

looking for a Quality Systems Engineer to provide support to the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and Good Manufacturing Practice (GMP). The successful applicant will: Implement and monitor established policies and procedures to … ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post Market Surveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the … relevant regulatory authority (ISO13485, Medical Device Directive MDD 93/42/EEC/Medical Device Regulation (EU) 2017/745 and 21 CFR Part 820) and local quality standards. Provide effective solutions/advice to design and manufacturing teams on established procedures to ensure products are designed and more »

To provide support to the management and improvement of quality systems processes to ensure both EU and US regulatory compliance to relevant company standards and Good Manufacturing Practice (GMP). • Implement and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the … Provision of advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the relevant regulatory authority (ISO13485, Medical Device Directive MDD 93/42/EEC/Medical Device Regulation (EU) 2017/745 and 21 CFR Part … Provide reports to management to enable them to monitor system performance. • Review and authorise documentation and processes in the Quality Management System to ensure compliance with established quality procedures and applicable regulations and alignment with other related documentation. • Identify and collaborate in the implementation of changes to the Quality more »

at St Mary's Pharmaceutical Unit (SMPU). The pharmacy clinical trials team based at SMPU Pharmacy (Field Way) provides trial set up and regulatory compliance and a preparative service for commercial and non-commercial trials requiring aseptic manipulation of patient doses. This activity is increasing year on … of the technical services pharmacy clinical trials services Supporting the lead and specialist pharmacists in the set-up of clinical trials Ensuring that all regulatory approvals are in place for clinical trials Providing day-to-day training, supervision and support to staff Monitoring Key Performance Indicators (KPIs) for clinical … and implement a dedicated preparative service for ATIMPs. coordination all clinical trial functions within aseptic services to meet the needs of the service. Ensure compliance to procedures and national standards (GMP, GCP and The Medicines for Human Use (Clinical Trials) Regulations 2004). About us Cardiff and Vale University more »