| Job alert | Jobs 41 - 50 of 753 |
Director, CMC Regulatory Affairs
Bayside Solutions
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Fremont, CA, 94537
... Participate in the interactions with FDA and other global regulatory authorities as appropriate. Provide regulatory assessment and guidance on CMC-related change controls, deviations, and investigations throughout the product life cycle. Participate ... - Jun 21
Facilities & Equipment Specialist
Xaira Therapeutics
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Foster City, CA
... Familiarity with regulatory requirements such as FDA, cGMP, and OSHA regulations pertaining to facilities and equipment maintenance. Excellent organizational skills with the ability to prioritize tasks and manage multiple projects simultaneously. ... - Jun 12
Clinical Software Verification Engineer
INTELLECTT INC
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Palo Alto, CA, 94306
... Ensure testing complies with regulatory standards (FDA, ISO 13485, IEC 62304). Stay updated with industry best practices and regulatory requirements. Qualifications: Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering ... - Jun 24
Clinical Research Coordinator 2 (Hybrid)
Stanford University
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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. EDUCATION & EXPERIENCE ... - Jun 24
Software Verification Engineer (Clinical)
Intellectt INC
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Palo Alto, CA
... Compliance and Standards Ensure testing activities comply with relevant regulatory standards (e.g., FDA, ISO 13485, IEC 62304). Stay updated with industry best practices and evolving regulatory requirements for medical device software Education: ... - Jun 19
Complaint Coordinator
Intellectt INC
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Livermore, CA
... 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 19
Clinical Research Coordinator 2
Stanford University
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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: 3 – ... - Jun 24
Senior Staff Regulatory Affairs Specialist (Remote - Pacific time zone
Stryker
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Fremont, CA
... Monitors, researches and obtains information [via FOI] on FDA clearances/approvals of competitors, and proactively shares this information. For new, routine or ongoing issues, communicates with regulatory agencies. Prepares for meetings with ... - Jun 21
Chemist/ Formulation Technician
Della Infotech Inc.
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Sunnyvale, CA, 94085
... • 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
Installation Engineer - HYBRID
RefleXion Medical
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Hayward, CA
... 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 ... - Jun 22