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FDA jobs in Fremont, CA

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Complaint Coordinator

GTT, LLC  –  Livermore, CA, 94550
... Demonstrates thorough understanding of quality management standards as outlined in Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs), and ISO 13485. Actively participates in departmental process improvements and effectively ... - Jun 21

Regulatory Affairs Manager

AbbVie  –  South San Francisco, CA
... Serve as HA liaison with FDA for routine communications in support of filings including complete & timely responses during application review. Write regulatory documents such as meeting requests &/or briefing book activities), & lead draft review ... - Jun 08

Quality Control Technician

Primo Water Corporation  –  Milpitas, CA
... Ability to become a Preventive Controls Qualified Individual (PCQI) as part of the FDA Food Safety Modernization Act (FSMA) requirements. Ability to become a Safe Quality Food (SQF) Practitioner (Only required in MV & CAN). Ability to support ... - Jun 21

Senior Technical / Product Support Engineer - HYBRID

RefleXion  –  Hayward, CA, 94540
... Designated an FDA Breakthrough Device for lung tumors, RefleXion's SCINTIX biology-guided radiotherapy aims to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease. FDA-cleared SCINTIX therapy automates targeting ... - Jun 24

Clinical Research Operations Specialist II

Stanford University  –  Stanford, CA, 94305
... Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. DESIRED QUALIFICATIONS: Clinical research certification from ACRP, ... - Jun 24

Manager, Food Safety Program - Corporate - US

SYSCO  –  Fremont, CA, 94537
... Ensure compliance with applicable food safety regulatory requirements (Federal, State/Provincial and, Local) including US FDA Seafood HACCP, FSMA Preventive Controls for Human Foods, FSVP, 204 Traceability Rule, USDA National Organic Regulations, ... - Jun 24

Cancer Clinical Research Coordinator 2 - Thoracic

Stanford University  –  Stanford, CA, 94305
... Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. * - Other duties may also be assigned. DESIRED QUALIFICATIONS: ... - Jun 24

Clinical Research Coordinator 2 (Fixed-term 2 years)

Stanford University  –  Stanford, CA, 94305
... Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. * - Other duties may also be assigned DESIRED QUALIFICATIONS: ... - Jun 24

Clinical Trial Associate

RICEFW Technologies  –  Foster City, CA
... Complete knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) ... - Jun 23

Formulation Chemist - Urgent (Entry Level)

Della Infotech Inc.  –  Sunnyvale, CA
... • Knows, fully understands the purpose of operational practices, health & safety regulations, OSHA requirements, and ISO9000/ISO13485/FDA 21CFR820 quality procedures, and works accordingly. • Ensures that health and safety procedures are adhered to ... - Jun 21
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