Experience

Invivoscribe

• United States
• Biotechnology Research
• 100 - 200 Employee

• Sr. RA

  • Jun 2022 - Present



Grifols USA, LLC

• Regulatory Affairs Specialist

  • Oct 2021 - Apr 2022



Stryker

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Regulatory Affairs Project Associate

  • Dec 2020 - Aug 2021

  Fremont, California, United States - Built and submitted EU MDR submissions for neurovascular products class IIb and III. - Developed a Python tool to automate document processing for submissions. - Used Pandas data frames to join selected regulatory data from multiple databases. The data was used to seed a database.



Thermo Fisher Scientific

• United States
• Biotechnology Research
• 700 & Above Employee

• Quality Specialist

  • Nov 2018 - Aug 2019

  - Managed IVD control project: provided project timeline, organized meetings, generated meeting minutes, compiled DHF documents, and supported interdepartmental activities to complete project milestones - Scoped production documents impacted for products as a result of production instrument migration to protect an estimated annual revenue of million dollars. - Assessed DHF and Technical File to prepare for IVD-R: gathered information from the for IVD-R strategic meetings, applied… Show more - Managed IVD control project: provided project timeline, organized meetings, generated meeting minutes, compiled DHF documents, and supported interdepartmental activities to complete project milestones - Scoped production documents impacted for products as a result of production instrument migration to protect an estimated annual revenue of million dollars. - Assessed DHF and Technical File to prepare for IVD-R: gathered information from the for IVD-R strategic meetings, applied strategy to site-wide specific products, communicated to sub-team members in completing required tasks to meet project timeline. - Evaluated critical attributes for purchased and in-house made raw materials to help the company close the gap in material qualification.

• Technical Application Specialist

  • Aug 2015 - Nov 2018

  Fremont - Performed statistical analysis of linearity, stability, cross-reactivity, and method comparison studies (correlation analysis, such as t-test) of patient samples; prepared technical reports to support instrument equivalency claims. - Designed application parameters, such as reagents/sample volumes and reaction timing for antibody-based assays. Optimized kinetic reaction curves that produce strong signals for low and high assay detection limits. - Supported business development… Show more - Performed statistical analysis of linearity, stability, cross-reactivity, and method comparison studies (correlation analysis, such as t-test) of patient samples; prepared technical reports to support instrument equivalency claims. - Designed application parameters, such as reagents/sample volumes and reaction timing for antibody-based assays. Optimized kinetic reaction curves that produce strong signals for low and high assay detection limits. - Supported business development managers: addressed business partners and customers’ technical questions/concerns during and after application development that extended existing business relationships. - Trained new team members on assay and parameters development on antibody-based assay technology.



Thermo Fisher Scientific

• United States
• Biotechnology Research
• 700 & Above Employee

• Associate Chemist

  • 2012 - 2015

  Fremont Formulated and performed functional testing of reagents, calibrators, and controls for DAU/OFT/TDM CEDIA immunoassays

• Research Associate Scientist

  • 2011 - 2012

  Fremont - Performed verification/validation studies on TDM products for FDA 510(K) submissions - Optimized immunoassay reagent formulations