NILOOFAR FARHANG BOROUJENI
Salt Lake City,UT
Summary
Regulatory Affairs Professional with 5.5 years of experience in the biomedical industry, working directly with regulatory professionals and as a regulatory professional for 3 years. Relevant experience involves aiding in authoring regulatory submissions and reports, as well as process development to aid in maintaining regulatory compliance.
Overview
11
11
years of professional experience
Work History
Regulatory Affairs Specialist I
ARUP Laboratories
11.2022 - Current
- Authored 24 post market reports for CE Marked In Vitro Diagnostic (IVD) Products
- Manage complaint handling, and feedback for 4 IVDs (1 CE Marked and FDA Approved, 3 CE Marked)
- Implemented 3 new processes for maintaining compliance with post-market surveillance requirements for FDA approved and CE marked IVDs
- Performed major updates to 2 processes regarding device complaints and reporting
- Monitored adverse events regarding 2 clinical trials
- Coauthored 2 successful IDE progress reports
- Assisted in maintaining compliance with device labeling requirements
Medical Writer/Editor II
ARUP Laboratories
08.2021 - 11.2022
- Aided in finalizing documentation across various departments
- Updated documentation to meet current procedures/processes
- Synthesized and edited documentation for device verification and validation activities
- Aided in compiling data for reports for regulatory submissions
- Collection, analyzing and organizing of source data input into technical reports
Sr. Analytical Scientist
DiscGenics
12.2019 - 07.2021
- Substantially contributed to 3 research publications
- Provided data figures and text for regulatory submissions and patents
- Produced 5 lab equipment SOPs and 4 test methods
- Plan and lead execution of qualifications for 4 potency assays
- Trained analytical team on test methods for potency assays
Graduate Research Assistant
University of Utah
08.2014 - 11.2019
- Produce technical documents (SOPs, Journal Publications, Book Chapters)
- Collect data and produce figures for 3 funded grants, 2 patent applications, and 6 publications
- Present research at 11 national and international conferences (5 oral, 6 poster)
- Mentor 4 undergraduate students to completion of thesis projects
Student Director/Associate
Lassonde New Venture Program
08.2017 - 05.2019
- Lead 3 projects regarding development of business plans for startups
- Perform market research for product commercialization
- User Surveys, Competitor Research, Regulatory Analysis
- Work effectively in cross disciplinary teams to achieve project goals
- Provide investor pitch deck for inventors to use in obtaining funding
Education
Ph.D. - Biomedical Engineering
University of Utah
Salt Lake City, UT10.2019
Honors BSc - Biomedical Engineering (Chemistry Minor)
University of Utah
Salt Lake City, UT12.2013
Skills
- Post Market Surveillance
- IVDs
- CE
- Data Analysis and Visualization
- Adobe Illustrator and Photoshop
- Microsoft Office
- Product Market Research
- Data Integrity
- Statistical Analysis (JMP SAS)
- Quality Management Systems
Leadership Roles
- Lassonde New Venture Development Student Director, 08/01/18, 05/01/19
- Graduate Women in Bioengineering Professional Development Chair, 08/01/17, 08/01/18
- Bioengineering GSAC Outreach Chair, 01/01/14, 12/01/16
- Bioengineering GSAC Treasurer, 08/01/16, 08/01/17
Timeline
Regulatory Affairs Specialist I
ARUP Laboratories
11.2022 - Current
Medical Writer/Editor II
ARUP Laboratories
08.2021 - 11.2022
Sr. Analytical Scientist
DiscGenics
12.2019 - 07.2021
Student Director/Associate
Lassonde New Venture Program
08.2017 - 05.2019
Graduate Research Assistant
University of Utah
08.2014 - 11.2019
Honors BSc - Biomedical Engineering (Chemistry Minor)
University of Utah
Ph.D. - Biomedical Engineering
University of Utah
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