Wokingham, England, United Kingdom Hybrid / WFH Options
Intersurgical
compliant to EU/UK MDR (Medical Device Regulation) Identifying, interpreting, evaluating and incorporating information from various sources appropriate to the device Analysing post-marketsurveillance data and risk management data to ensure consistency and alignment in CER (Comparative Effectiveness Research) Evaluating clinical evidence from published literature, post … marketsurveillance, risk assessments and post-market clinical data, and be able to generate a report of these data Ensure that Clinical Evaluation Plans/Reports and databases are kept compliant and up to date Managing timelines and communication to ensure deliverables and milestones are met Assisting more »
Cardiff, South Glamorgan, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post MarketSurveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post MarketSurveillance … Employee Assistance Programme About ATL Technology ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site is based in St Mellons, Cardiff. We believe that there is a better way to bring medical devices to marketmore »
Cardiff, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post MarketSurveillance and Non-conformance Report (NCR). Provision of advice according to established procedures relating to CAPA, Complaint, Post MarketSurveillance … Employee Assistance Programme About ATL Technology ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site is based in St Mellons, Cardiff. We believe that there is a better way to bring medical devices to marketmore »
and monitor established policies and procedures to ensure compliance with necessary regulatory bodies in the areas of: Corrective and Preventive Action (CAPA), Complaint, Post MarketSurveillance and Non-conformance Report (NCR). • Provision of advice according to established procedures relating to CAPA, Complaint, Post MarketSurveillancemore »
Main responsibilities: Design and develop system-based nucleic acid assays. Design and perform experiments, prepare technical reports, analyze data sets and present results. Post Market Surveillance. Evaluation and validation of assay performance against assay requirements. Development/preparation of quality system procedures and documentation. Transfer laboratory-developed assays to more »
IVD Directive (98/79/EC). Lead strategies for a large product portfolio including supporting new registrations, authoring technical files, and post-market surveillance. A minimum of 8 years post-qualification experience in regulatory affairs in the medical device and/or pharmaceutical industry in product registration more »