Jocelyn Cleta Mathanraj Email & Phone Number

As a project assistant at Microbio, I contribute to the development of innovative diagnostic products for sepsis and COVID-19, which have the potential to improve public health outcomes and save lives. I perform a diverse range of roles including quality management documentation (ISO:13485), literature reviews, regulations, competitor analysis, grant applications, etc. I am passionate about the application and commercialization of scientific research, especially in the field of biopharmaceuticals and medical devices.

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  Project Assistant

  Microbio

  Aug 2020 - Present - Melbourne, Victoria, Australia

  Software team:● Preparing, updating and reviewing SDLC documentation in accordance with IEC 62304:2015● Performing software validation testing and writing test documentation.● Writing documentation such as user guides, LIMS integration guides, etcRegulatory affairs:● Completed literature review for IVDR PEP (Performance Evaluation Plan).● Compiling technical file for IVDD submission.● Comparing regulatory requirements and guidelines for product approval in different jurisdictions and presenting concise overviews to the strategic leadership team.Commercialisation/Business development:● Compiled thorough competitor analysis to guide design and development.● Preparing literature reviews on sepsis prevalence, cost-effectiveness of various diagnostic methods, patient outcomes, etc to present to investors and to inform commercial strategies.● Preparing research for ECCMID and other conferences.Quality management:● Creating quality management documents for ISO-13485 certification● Completing project initiation and input documents for design and developmentOther:● Compiling information and documentation for grants.● Established efficient customer relationship management (CRM) systems.● Contributed to setting up a data room.● Compiling project management documentation.● Setting up and maintaining Zotero to manage journal articles.● Organising employment contracts.