| Job alert | Jobs 1 - 10 of 473 |
CMC Quality Control Manager
GQR
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South San Francisco, CA, 94083
... Ensure all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies. Support the development and validation of analytical methods used for QC testing. Implement and maintain quality systems to ... - Apr 19
Products Liability Partner
Ascension Global Staffing & Executive Search
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San Francisco, CA
... Regulatory experience with the Consumer Product Safety Commission (CPSC) or the Food and Drug Administration (FDA) is a significant advantage. This position is vital to our succession planning, as some of our senior attorneys are nearing retirement. ... - Apr 06
Medical Science Liaison, Hematology/Oncology (Northern CA)
TMAC's Direct Hire (Executive Search) Service
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San Francisco, CA
... They have received priority review from the FDA for two of their assets. They are looking for experienced MSLs who are working in the myeloma or lymphoma space. This is a can’t miss opportunity! Territories: Northern IL/WI Northern Cal/NV Pacific ... - Apr 28
RA Specialist II
DivIHN Integration
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Alameda, CA, 94502
... Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc. Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency. Ability to manage time and projects. Strict to work 40hrs per ... - May 02
Regulatory Specialist
Prenuvo
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San Francisco, CA
... What You'll Do Regulatory Submissions: Prepare, submit, and update pre-submission packages, Q-sub/supplements/amendments & RA submission pathways compliant with 21CFR820, 21CFR892, and FDA guidance documents Prepare justifications for intended use, ... - Apr 19
Quality Engineer I/II
Medical Instrument Development Laboratories, Inc.
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San Leandro, CA, 94579
... Support company goals and objectives, policies and procedures, FDA Quality System Regulation-21 CFR, part 820, EU MDD/MDR and applicable global standards and regulations. Performs other duties as assigned by Supervisor. REQUIRED EXPERIENCE: ... - Apr 26
Clinical System Lead
Intelliswift Software
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South San Francisco, CA, 94080
... in leading the implementation of clinical systems, such as IxRS/IRT, ePRO and eCOA Working knowledge of Good Clinical Practices and FDA regulations governing clinical trial execution Detail-oriented and able to manage many projects simultaneously. ... - Apr 23
Lead Building Maintenance Technician
ThermoFisher Scientific
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San Francisco, CA
... Food and Drug Administration (FDA) regulations, EMA (European Medicines Agency), other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and ... - May 02
Senior Manager, Clinical Data and Reporting Standards (Remote)
AbbVie
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San Francisco, CA
... Review and provide feedback on SDTM Trial Design Domains Oversee the creation of SDTM define.xml, annotated CRF and Clinical Study Data Reviewer’s Guides for both FDA and PMDA submissions. Consult on conformance issues for SDTM and/or ADaM and work ... - Apr 17
Design Engineer- Facilities and Utilities
Azzur of CA
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San Francisco, CA
... Experience with cGMP and FDA compliance is essential. Essential Duties and Responsibilities Write technical documents associated with projects. Write engineering and design specifications (URS/FS/DS) for facility and utility systems. Perform (hands ... - Apr 13