to make a meaningful impact in the diagnostics industry? We're seeking a dedicated individual to join our client's team as a Post-MarketSurveillance Coordinator. Reporting to the Regulatory Affairs Manager, you'll take on the crucial responsibility of coordinating all required post-market activities … ensuring compliance with regulatory reporting timelines, and fulfilling our post-market obligations. As Post MarketSurveillance Manager key responsibilities: * Coordinate post-marketsurveillance tasks aligned with QMS policies and international regulations. * Ensure individual product Post MarketSurveillance plans are implemented effectively. * Collaborate with 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 »
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 »
worldwide. This person will also be responsible to build, implement and maintain regulatory compliance processes including, regulatory evaluation of changes and non-conformances, post-marketsurveillance, vigilance and associated reporting, regulatory and standard watch. Requirements include A relevant degree and/or relevant work experience in a regulatory … affairs environment. Experience in medical device/IVD/biotech industry. Experience in post market surveillance. If this is of interest, please get in touch for a confidential conversation more »