TEC Partners are working with a London-based bio-med company that develops microfluidic medical testing devices to address the need of high-throughput lab and mobile testing, as well as cloud-connected portable testing technologies.
Their products have proven to provide laboratory-level accuracy with only a fraction of time and cost needed compared to conventional PCR testing. The technology is already being applied to a range of most common diseases and infections, allowing for diagnosis at the very early stages.
They are currently looking for a Senior Project Manager to oversee the development and commercialization of IVD products. The ideal candidate would have a strong background in project management in IVD industry and a good knowledge of ISO13485 standard.
* At least 3 years of project management experience in IVD industry* Project Management certification* Degree and practical experience in science, engineering, or related subject* Significant experience working in a regulated environment: ISO13485, ISO14971, IVDR, FDA QSR, MHRA and GMP/GLP/GCP standards* Previous experience working in a laboratory or manufacturing environment* Strong problem-solving skills applying scientific knowledge
* Immunoassay knowledge* IVD product manufacturing experience, IVD reagents and/or protein lyophilisation experience* Knowledge of ISO62304, ISO62366, ISO60601
* Project creation, execution, planning, and management* Project documentation* Development of Risk Management activities* Work with QA/RA on medical device regulatory requirements* Technical and manufacturing problem solving* Process improvements for efficiency and accuracy* Inter-departmental work to implement new processes* Leading of data analysis and interpretation* Project and team meetings; presentations on progress
If this role sounds like a good match for your skills and experience, please apply with your updated CV or reach out to TEC Partners Recruitment to find out more details about the role and the company.