Rebecca Leigh
Project Manager
Barrington,IL
Summary
Bilingual project manager with experience in molding and medical device clinical research studies. A resourceful and performance-driven individual capable of monitoring the development and implementation of projects, FDA submissions, and specializing in cross-functional communication. Seeking a stimulating and rewarding environment to utilize a blend of skill and passion.
Overview
5
5
years of professional experience
4
4
Certificates
1
1
Language
Work History
Project Manager
Abbott
05.2023 - Current
- Designated as project manager in engineering division for Abbott diagnostic products
- Specialized in managed molding, automation and commodity related projects
- Led projects through feasibility, equipment upgrades, design changes, material changes and obsolesces
- Developed comprehensive project plans with clear timelines, milestones, and budget
- Established effective communication and relationships among team members in multiple countries and US states
- Closely collaborated with senior management to align project priorities and strategic company initiatives
- Utilizing SAP, Ariba and Microsoft Excel to closely manage budgets and calculate gross margin improvements
Project Coordinator II
BioMerieux, Inc
01.2022 - 02.2023
- Positioned as program management representative for Molded Parts and Plastic Engineering team
- Managed 25+ molds in development timelines in MS project and prioritized based on resources and company goals
- Implemented fundamental timeline durations using historical and statistical data for 6 types of plastic-injected molded parts
- Orchestrated weekly company plastic engineering meetings, ensured stakeholders were present as appropriate for agenda items, and reported on new development timelines
- Designed/executed Asana structure for entire program management department, including training and presenting, to track programs and projects.
Clinical Regulatory Affairs Research Associate
BioFire Defense (Subsidiary of Biomerieux)
12.2020 - 1 2022
- Monitored, tracked, and closed out 14 clinical research sites (12 international) while meeting all IRB/IEC and HRPO regulatory requirements
- Organized study paperwork data verification wrote FDA-related submission documents, as well as monitored project progress, and adjusted timelines accordingly
- Wrote and verified documentation for one de novo, three 510(k), and four EUA submissions
- Designed data verification structure and timeline
- Tracked progress and assigned research associates appropriately to tasks accordingly to meet FDA and DOD submission deadlines.
Clinical Regulatory Assistant
BioFire Defense (Subsidiary of Biomerieux)
02.2019 - 12.2020
- Maintained consistent coordination with the clinical research project manager for an IVD medical device clinical trial and supported the consequent de novo and 510(k) submissions
- Ensured seamless day-to-day operations by managing shipments of supplies, instruments, and samples from domestic and international clinical research sites
- Monitored incoming study paperwork and data for 14 clinical site simultaneously, Delivered proactive support regarding the creation and implementation of in-house covid screening testing protocol, while managing and ensuring operator-blinded sample handling.
Education
Bachelor of Science - Biology, Cellular And Molecular
The University of Utah
Salt Lake City, Utah2020
Skills
Microsoft Excel
undefinedCertification
AAMI Design Control Requirements Course
Timeline
Project Manager
Abbott
05.2023 - Current
Project Coordinator II
BioMerieux, Inc
01.2022 - 02.2023
Clinical Regulatory Affairs Research Associate
BioFire Defense (Subsidiary of Biomerieux)
12.2020 - 1 2022
Clinical Regulatory Assistant
BioFire Defense (Subsidiary of Biomerieux)
02.2019 - 12.2020
Bachelor of Science - Biology, Cellular And Molecular
The University of Utah
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