Angela Y.

About Angela Y.

Regulatory Affairs & Quality Assurance specialist with strong training in Biochemistry and Cell Biology and hands-on experience in in vitro diagnostic research & development, translational research and medical device industries. Experienced working in CLIA, ISO 13485-compliant, GLP/GMP facilities. Regulatory experiences include FDA 21 CFR Part 820, EU MDR/IVDR, international product registrations, conducting FDA Human Factors and Usability Engineering, authoring Clinical Evaluation Reports and document control. Scientific research skills include clinical coordination, assay development, cell culture, clinical sample (blood, saliva, urine) processing, RNA fluorescence in situ hybridization (FSH), ELISA, flow cytometry, Verification & Validation.

Experience

1. Senior Manager Regulatory Affairs (a Roche Subsidiary)

   Foundation Medicine

   Oct 2024 — Present · San Diego, CA, US

   Provide regulatory support to cross-functional teams throughout the product development lifecycle, from design input through each development exit, ensuring compliance with applicable standards and regulations- Lead FDA Pre-Submissions for devices targeted for U.S. PMA (Class and EU IVDR (Class A sterile; Class C) submissions, guiding regulatory strategy during new product development for the following products: • FMI FoundationOne Heme CDx (F1HCDx) assay• FMI FoundationOne RNA CDx (F1RNACDx) assay- Ensure new FMI comprehensive genomic profiling (CGP) CDx products are developed and validated to standards required for FDA-regulated products and for inclusion as part of a drug or diagnostic regulatory approval submission (PMA, NDA, EU IVDR)- Perform Significant Risk (SR) and Non-Significant Risk (NSR) per FDA IDE regulation 21 CFR 812 to support clinical study determinations- Lead regulatory review of CPSPs and submission requirements for clinical trial approvals under EU IVDR and UK MDR- Facilitate external partner collaboration to support U.S. and global clinical trial study execution- Conduct Regulatory Impact Assessment for changes related to regulated products by U.S. FDA, CLIA/CAP/New York State LDT, EU IVDD/IVDR, Japan PMDA, and products intended for clinical study under an IDE or performance evaluation- Represent Regulatory Affairs on the Medical Review Committee (MRC) to review and ensure compliance of promotional claims with regulatory standards.

Education

• Johns Hopkins University Advanced Academic Programs

  Master of Science (M.S.), Regulatory Science

• UC San Diego

  Bachelor of Science (B.S.), Biochemistry and Cell Biology

  2006 — 2011

• University of California, Riverside

  Transformative Leadership in Disruptive Times Executive Program Advisory Board

Skills

• Intellectual Property
• Life Sciences
• Cell
• Data Analysis
• Graphpad Prism
• Cell Culture
• Biochemistry
• Cancer Research
• Cell Biology
• Microbiology
• Mammalian Cell Culture
• Biotechnology
• Genetics
• Laboratory Skills
• Immunohistochemistry
• Molecular Biology
• Clinical Trials
• Elisa
• Assay Development
• Laboratory
• Cancer