Ashley Vu

About Ashley Vu

Extensive background working in team atmospheres and applying strong communication skills. Effective organizational and leadership skills. Can provide a friendly, enthusiastic, fresh personality and perspective to any task given. Extremely motivated, hard working, and believes in the importance of quality. Displays a passion for biotechnology and health awareness in the community. Has the following areas of expertise: • FDA, IVDD, IVDR, Code of Federal Regulations (CFR), CDRH• ISO 13485, MDSAP CFR 820, GMP, GLP and GDP Compliance• Regulatory Requirements for Marketing, Promotional• Compliance, and Product IFUs/Labeling• FDA Class I/510(k) exempt, Class IVDD Annex II product requirements and regulatory strategy• Full Product Life Cycle for Assay, Software, and Instrumentation Design and Development• Data Trending, Root Cause Identification, CAPA Analysis,Effectiveness Checks, Risk/Benefit Analysis• Internal/External Compliance and Quality Auditing• Technical File & Design Dossier compilation and maintenance• Technical Skills: Microsoft Office Suite, Apple Products, SAP, Master Control, Agile, Doc Lib, Scrum• Laboratory Techniques – PCR, Sample/Tissue Preparation & Analysis, Assay Testing, Hybridization, Genotyping

Experience

1. Regulatory Affairs Manager

   Thermo Fisher Scientific

   Apr 2021 — Present · San Francisco, CA, US

   Lead US EUA regulatory submissions for COVID-19 diagnostic product line (PCR assays/instrumentation) and provide guidance for product global registration activities.• Facilitate and prepare US regulatory pre-submission documents for infectious disease PCR assays/instrumentation including (510 (k)), PMA, and EUA.• Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements.• Perform regulatory assessment of new and changed products.• Conduct trainings and / or communicate appropriate materials, as needed, in order to enhance team\'s knowledge of working in a regulated environment.• Participate in business meetings with potential new external partners for regulatory strategy to bring products to market.• Lead Site Regulatory Affairs (Pleasanton) for manufacturing site in design change, post-market reporting, quality management, point of contact for regulatory authorities, regulatory lead for site quality audits. • Leads market expansion initiatives with Rest of World Health Organizations such as EU IVDD/IDVR, ANVISA, NMPA, WHO, TGA, Health Canada, etc.

Education

• UC San Diego

  BIochemistry, Cell/Cellular and Molecular Biology

  2008 — 2012

Skills

• Pcr
• Html
• Nonprofits
• Microsoft Office
• Photoshop
• Data Analysis
• Public Speaking
• Microsoft Word
• Event Planning
• Microsoft Excel
• Powerpoint
• Social Media
• Research
• Fundraising
• Program Management
• Facebook
• Community Outreach