Kaila Glassburner
Medical Device Reporting Specialist II
Portland,OR
Summary
Data-driven Reporting Specialist with years of experience designing and developing reports to meet customer needs. Analyzes data while identifying trends and initiating improvement actions. Collaborates across departments to develop, test and implement updates to FDA reporting procedures using Salesforce and SAP. Expertly collects, organizes, analyzes and disseminates significant amounts of information to diverse audiences through in-house presentations and training sessions.
Overview
12
12
years of professional experience
7
7
years of post-secondary education
1
1
Language
Work History
Medical Device Reporting Specialist II
Biotronik
Lake Oswego, OR
05.2019 - Current
- Analyzed complaint submissions and applied Medical Device Reporting regulations (21 CFR Part 803) to determine FDA reportability. Decreased average MDR reporting time by over 10 days within first year of employment.
- Created Salesforce reports to analyze data, compile and visualize historical information regarding complaints and adverse event reporting.
- Supported teams across departments seeking resolution to issues discovered during report and data analysis by updating department practices and SOPs.
- Collaborated with Salesforce Admin team in development and testing of new Salesforce system updates and enhancements to better serve customers and field sales representatives.
- Led in-house training programs covering complaint reporting processes in Salesforce, company policies, and FDA compliance requirements for Medical Device manufacturers and field sales representatives.
Science Teacher
Tualatin High School
Tualatin, OR
08.2018 - 01.2019
- Leveraged diverse learning strategies to prepare students for higher-level education requirements by developing 3 novel hands-on inquiry labs for the department.
- Coordinated and collaborated with other faculty members to increase equity and inclusion in department curriculum.
SAT Prep Instructor
Hispanic Foundation Of Silicon Valley
San Jose, CA
03.2015 - 05.2018
- Used data-driven practices to improve student scores by 10-15% in each 6 week course.
- Collaborated with parents, teachers, and community members to promote equity and inclusion and close equity gap in SAT scores for students of color.
Science Teacher
James Lick High School
San Jose, CA
08.2014 - 05.2018
- Designed and implemented new curriculum in Forensic Science, Physiology, and AP Biology. Used project-based learning and inquiry lab techniques to engage students and enhance subject mastery.
- Managed multiple concurrent projects and consulted across the Science, English, and Art departments to meet cross-curricular learning objectives.
Assistant Store Manager
Peet's Coffee & Tea
Los Gatos, CA
11.2010 - 01.2013
- Coached sales associates in product specifications, sales incentives and selling techniques, significantly increasing customer satisfaction ratings with an average score of 3.75/4 on all secret shopper events.
- Applied sales data to evaluate and improve flow-through, manage inventory, and evaluate staffing needs across multiple Bay Area stores.
Education
Single Subject Teaching Credential - Biology & Chemistry
San Jose State University
San Jose, CA 08.2013 - 05.2015
Bachelor of Science - Molecular, Cell, And Developmental Biology
University of California, Santa Cruz
Santa Cruz, CA 01.2008 - 06.2010
Transfer Studies - Chemistry
American River College
Sacramento, CA 08.2004 - 12.2007
Skills
Training & Development
Writing and Revising Technical Documents
Written & Oral Communication
Data Analysis and Report Building in Salesforce
FDA and ICH Guidelines
Presentation Skills
Medical reporting
Clinical Trials
Statistical reporting
Claims reporting systems
Microsoft Office
Accomplishments
- James Lick High School Teacher of the Year, 2017
- BIOTRONIK SPOT Award - Dedication to Quality, Q2 2020
- BIOTRONIK SPOT Award - Expertise Across All Areas, Q3 2021 (nominee)
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Medical Device Reporting Specialist II
Biotronik
05.2019 - Current
Science Teacher
Tualatin High School
08.2018 - 01.2019
SAT Prep Instructor
Hispanic Foundation Of Silicon Valley
03.2015 - 05.2018
Science Teacher
James Lick High School
08.2014 - 05.2018
Single Subject Teaching Credential - Biology & Chemistry
San Jose State University
08.2013 - 05.2015
Assistant Store Manager
Peet's Coffee & Tea
11.2010 - 01.2013
Bachelor of Science - Molecular, Cell, And Developmental Biology
University of California, Santa Cruz
01.2008 - 06.2010
Transfer Studies - Chemistry
American River College
08.2004 - 12.2007