- Fujifilm (Sacramento, CA)
- …to work on customer systems. + Adheres to the Company's quality and regulatory compliance requirements, without exception, and ensures that all job duties ... + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements… more
- Bayer (Berkeley, CA)
- …New Product Introduction is beneficial; + Strong understanding of data integrity, regulatory requirements ( FDA , EMA, etc.), and cGMP requirements for ... for the CT-MOD team. Delivers training. Ensures own training is always in compliance . Modifies shift patterns & working hours when needed and at short notice… more
- Imperative Care (Campbell, CA)
- …with customer representatives, marketing, physicians, pre-clinical engineering, and regulatory affairs to understand user interactions, identify product ... project team to ensure products are designed, developed, and manufactured in compliance with customer needs, company quality systems, budget, schedule and … more
- IQVIA (Valencia, CA)
- …across project teams to organize timelines, responsibilities, and deliverables + Uphold compliance with SOPs, regulatory guidelines, and Good Clinical Practice ... deadlines and deliverables + Proficiency in laboratory terminology and regulatory standards including FDA , GLP, ICH, ISO...in laboratory terminology and regulatory standards including FDA , GLP, ICH, ISO HL7 + Excellent problem-solving and… more
- Cedars-Sinai (Beverly Hills, CA)
- …of technical and supportive patient care tasks in accordance with facility and regulatory requirements. **We are currently offering a $5,000 sign-on bonus to newly ... supplying necessary equipment and performing vascular site management, while supporting FDA approved and clinical research procedures. + Performs all diagnostic… more
- J&J Family of Companies (Santa Clara, CA)
- …+ Lead the software development for medical device product(s) in full compliance with the company's Design Control requirements and consistent with FDA ... + Initiate and conduct software system code reviews. + Develop documentation per regulatory body guidelines. + Interface with internal regulatory affairs and… more
- Abbott (Alameda, CA)
- …+ Knowledge of data collection best practices for clinical trials familiarity with regulatory frameworks (eg, FDA , EMA, ICH-GCP). + Knowledge of global clinical ... for maintaining comprehensive research documentation for audits, inspections and regulatory submissions. Develop and/or conduct the continuous review the IQRMP… more
- Gilead Sciences, Inc. (Foster City, CA)
- …with containerization and orchestration tools (eg, Docker, Kubernetes). + Knowledge of AI-related regulatory frameworks (eg, HIPAA, GDPR, FDA , EU AI Act). + ... as marketing, sales, and strategy across G9 countries while ensuring alignment with regulatory frameworks (eg, EU AI Act) and ethical standards. You will also… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for clinical studies, and, in comparator sourcing strategy. + Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, ... Work Instructions, business policies and procedures to ensure GxP compliance . Influence cross-functional SOP content and review/approve as required....EU CTR. Able to support regulatory inquiries both face-to-face and with appropriate responses. +… more
- Envista Holdings Corporation (Brea, CA)
- …audit firm methodologies. + Practical experience and expertise in IT compliance and regulatory requirements, such as SOX 404, FDA 21 CFR Part 820, and ... implementation status of recommendations made in previous audits. + Ensure compliance with professional standards (eg, Global Internal Audit Standards (GIAS)) while… more