| Job alert | Jobs 21 - 30 of 752 |
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 01
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
Quality Engineer - Hybrid
Cannon Quality Group
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Brisbane, CA, 94016
... suppliers and vendors EXPERIENCE REQUIREMENTS: 2+ years of in-depth Quality System implementation in compliance with FDB, FDA, and ISO 13485 2+ years of multiple simultaneous project QA or client facing QA consultancy Experience should include ... - Jun 13
Machine Operator
Avanti MFG
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Milpitas, CA, 95035
... Distinguish between an FDA Product and non-FDA product and follow proper FDA rules and protocols when applicable. Collect standard samples and for QA testing. Add re-feed to the machines as needed. Perform manual/automatic operations of the Rewinder ... - May 23
Verification Engineer (Clinical) - Must to have Python,Java
Syncreon Consulting
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Palo Alto, CA, 94306
... 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 07
Computer systems validation engineer
Harvey Nash
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Newark, CA, 94560
... Knowledge of validation of cGMP automation/computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex ... - Jun 18
Regulatory Affairs Specialist II Heart Failure
Abbott Laboratories
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Pleasanton, CA, 94566
... What You’ll Work On Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Acts as core team member ... - Jun 19
Regulatory Affairs Manager
AbbVie
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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
Director Quality Regulatory Affairs
Insight Global
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Pleasanton, CA, 94566
... In addition, this position leads CTP in a comprehensive knowledge of FDA, GCP, GDPR regulations and ICH E6 R2 guidelines. This position reports to the Managing Director, Clinical Trials Program Primary Duties and Responsibilities: ● Providing ... - Jun 02
Director, CMC Regulatory
Revolution Medicines, Inc.
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Redwood City, CA, 94063
... * 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. * ... - May 24