Marie Eccles

Marie Eccles

Histocompatibility Technologist

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location of Marie EcclesWashington DC-Baltimore Area

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  • Timeline

  • About me

    Regulatory Affairs Specialist | Expert in Medical Device Compliance, Project Management, and Clinical Laboratory Operations

  • Education

    • The Johns Hopkins University

      2018 - 2020
      Master in Regulatory Science Regulatory science
    • St. John's University

      1998 - 2003
      Bachelor of Applied Science (B.A.Sc.) Clinical Laboratory Science/Medical Technology/Technologist
  • Experience

    • Rogosin Institute

      Jan 2006 - Jan 2010
      Histocompatibility Technologist

      • Employed advanced CDC (ELISA) and molecular technologies for meticulous antibody screening, optimizing transplant compatibility assessments.• Utilized cutting-edge flow cytometry techniques for precise crossmatching in solid organ transplant procedures, mitigating the risk of rejection and enhancing patient safety.• Gathered and meticulously analyzed statistical data to drive quality control studies, ensuring the reliability and accuracy of laboratory results.• Played an essential role in the development, maintenance, and updates of standard operating procedures, ensuring strict compliance with regulatory agency standards and fostering a culture of continuous improvement. Show less

    • Abbott

      Aug 2010 - Dec 2013
      Technical Application specialist

      • Delivered remote support to Abbott Diagnostic customers and field personnel by managing over 20 daily calls using technical proficiency. • Attained 100% compliance to the quality system by documenting complaints and devised appropriate corrective actions. • Guided field service teams in resolving hardware and assay issues, leveraging expertise to streamline troubleshooting processes and reduce resolution times by 35%, ensuring optimal instrument performance and customer satisfaction. • Conducted instrument assay validation and assisted laboratories in fulfilling regulatory requirements. • Executed field repair initiatives for medical equipment, performing preventive maintenance and implementing software updates; increased equipment uptime by 25% and reduced service response time. Show less

    • QIAGEN

      Jan 2014 - Jan 2017
      Implementation Coordinator/Medical Devices

      • Facilitated laboratory Hematology and IACC instrument implementation projects for Abbott Laboratories distribution channel, planning and executing timelines that surpassed customer expectations. • Developed implementation plans based on client needs, fostering strong relationships and repeat business opportunities. • Optimized resource allocation with strategic planning and prioritization of tasks, resulting in timely project completion. • Managed the scheduling and performance for 8 Technical Application Specialists who covered all 50 states. Show less

    • DiaSorin

      Jan 2017 - May 2019
      Field Application Specialist

      • I played a pivotal role in successfully onboarding new customers, ensuring compliance with all aspects of assay validations and laboratory accrediting bodies requirements for the Diasorin IVD instrumentations. • Partnered with the sales teams to devise effective strategies for territory expansion and customer retention, resulting in a significant 35% growth in the assigned territory through new assay adoption. • Effectively use customer relationship management tools to track client interactions, opportunities, and sales forecasts. • Collaborated with cross-functional groups, such as sales and service, to manage 50+ accounts across the US and Canada and created solutions to promote customer satisfaction and retention. • Conducted regular follow-ups with client's post-implementation, ensuring continued success in achieving desired outcomes. • Identified areas for process improvement within client operations, resulting in cost savings and streamlined workflows. • Enhanced product adoption with tailored training sessions for, increasing client confidence and product usage by 100%. • Mentored junior team members, fostering professional growth through knowledge sharing and skill-building exercises. Show less

    • Abbott

      May 2019 - now

      • Facilitated the compliance with FDA and BSI regulations and standards for medical devices, including 510(k) submissions, by assisting the regulatory affairs teams. • Advised on regulatory compliance strategies and implemented remediation plans, ensuring product quality and adherence to industry standards, resulting in zero compliance issues and customer complaints. • Championed cross-functional projects by uniting R&D, Packaging, Operations, Regulatory, and Quality teams towards successful EU MDR Technical File submissions within set budget and time constraints. • Cultivated and nurtured relationships with executive-level stakeholders through monthly progress updates and personalized communications, ensuring continuous support for program initiatives and achieving a 95% approval rate on proposed changes. • Led the formulation of strategic initiatives, setting specific performance indicators and realistic milestones for the team which resulted in increased team productivity and accelerated product development timelines. • Guided project teams strategically, fostered vendor relationships, and presented succinct status updates to C-suite executives, resulting in enhanced project delivery efficiency and stakeholder satisfaction. Show less • Drove the implementation of approximately 100+ Abbott Laboratory instruments in medical diagnostic laboratories. • Engineered user-oriented project plans in collaboration with interdepartmental teams to meet revenue goals and enhance user experience; delivered 100% customer satisfaction. • Leveraged technical knowledge of medical devices and clinical laboratory operations to provide strategic advice and operational solutions, enhancing project outcomes. • Adopted a responsive approach to managing project changes, risks, and issues, resulting in a 35% decrease in project delays and improved stakeholder satisfaction. • Recorded daily project updates and completed milestones in project tracker. • Executed resource allocation analysis, closely monitored project advancements, and mitigated risks through rigorous change control processes; optimized resource utilization, leading to a 20% increase in project efficiency. Show less

      • Program Manager Regulatory Affairs Electrophysiology

        Apr 2022 - now
      • Project Manager Diagnostic Implementation

        May 2019 - Mar 2022
  • Licenses & Certifications

    • Design and Interpretation of Clinical Trials

      Johns Hopkins University
      Nov 2024
      View certificate certificate