Heike Sander

Experience

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  Saarland University

  Oct 2008 - Aug 2016

  Wissenschaftlicher Mitarbeiter
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  DHC Dr. Herterich & Consultants GmbH

  Sept 2016 - Nov 2021

  Consultant
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  DHC Business Solutions GmbH & Co. Kg

  Oct 2020 - now

  Leading a team of scientists and engineers in the research and development of innovative AI solutions tailored for the Life Sciences industry.Directing and managing multiple publicly funded research projects applying AI to key areas such as Pharmacovigilance, automated regulatory Compliance, and process optimization within the medical device/Drug Development lifecycle.Playing a key role in the development and validation of AI-powered Software as a Medical Device (SaMD), ensuring compliance with relevant regulations (MDR, FDA, ISO 13485, IEC 62304) and best practices.Successfully launched SmartVigilance, an AI-powered software solution for automated post-market surveillance of medical devices (see [link to website/product page if available]).Developed and implemented an RPA-based solution for optimizing validation processes within quality assurance, significantly improving efficiency.Actively contributing to the AI community through publications, presentations at industry conferences, and collaborations with research institutions.Responsible for strategic planning, project acquisition, and budget management within the AI research department. Show less

  • Senior Research Manager

    Oct 2021 - now

  • Senior Researcher

    Oct 2020 - Nov 2021
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  Saarland University

  -

  Wissenschaftlicher Mitarbeiter