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Job alert Jobs 1 - 10 of 542

Ex-FDA Investigators and Reviewers

Pharmatech Associates  –  San Francisco, CA
... Posted Feb 29, 2024 Pharmatech Associates is seeking former FDA investigators and reviewers to provide consultation and remediation services to our pharmaceutical, biologics and medical device clients. The nature of our projects varies from client ... - May 02

CMC Quality Control Manager

GQR  –  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

Clinical System Lead

Intelliswift Software  –  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

RA Specialist II

DivIHN Integration  –  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

Senior Director Clinical Data Management

Meet  –  South San Francisco, CA, 94083
... Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., CDISC). Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders. Prior ... - Apr 26

MATERIAL SPECIALIST

Avinger, Inc  –  Redwood City, CA, 94063
... Practices, and FDA regulations Ensure that all internal policies are followed Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents. ... - May 01

Quality Engineer I/II

Medical Instrument Development Laboratories, Inc.  –  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

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 ... - May 01

Laboratory Asset Manager

Mentor Technical Group  –  South San Francisco, CA, 94080
Job Description Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and ... - Apr 26

Regulatory Specialist II

Spectraforce Technologies  –  Alameda, CA, 94501
... 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
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