Stefanie Kapucija
Oxnard
Overview
2
2
years of professional experience
Work History
Senior Research Associate
Agilent Technologies Inc.
Carpinteria
09.2023 - Current
- Design lead for the creation of a new Class III In Vitro Diagnostic Product (IVD) for a novel biomarker, leading the development of the device from optimization, analytical validation, and design transfer for commercialization.
- Experience with the FDA pre-submission process for a Class III IVD.
- Experience with De Novo Classification Process.
- Knowledgeable about In Vitro Medical Device Regulation.
- Resolving issues at clinical trial sites, successfully resolving the issue, and preventing patient harm and a reportable event.
- Commercialization of Class III IVDs.
- Training and implementation of technical procedures for newly developed IVD devices at clinical trial sites.
- Drafting of all technical documentation related to a Class III IVD.
- Monitored the progress of ongoing projects by tracking the milestones set out in project plans and contracts.
- Forecasted, scheduled and monitored project timelines, personnel performance, and cost efficiency.
- Monitored progress of each project to ensure timely delivery of deliverables in accordance with established quality standards.
- Presented findings from data analysis in a clear, concise manner that was easily understood by stakeholders at all levels of the organization.
- Facilitated resolution of conflicts between team members when necessary.
- Submitted project deliverables to clients, consistently adhering to quality standards.
- Conducted regular status meetings with internal teams and external partners to track progress against established milestones.
- Gathered and analyzed scientific data to formulate explanations and arguments for regulatory authorities.
Education
Bachelor of Science - Biotechnology
California State University Northridge
Northridge, CA07-2012
Skills
- Class III IVD products
- FDA pre-submission
- De-Novo Pathway and Classification
- IVDR
- Device optimization and commercialization
- Clinical trial support
- Interdisciplinary knowledge
- Resource management
- Technical documentation
- Project tracking
- Quality assurance
- Research and analysis
- Scientific writing
Timeline
Senior Research Associate
Agilent Technologies Inc.
09.2023 - Current
Bachelor of Science - Biotechnology
California State University Northridge
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