- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. **Primary Duties and Responsibilities:** + ... concerns regarding data quality and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit… more
- J&J Family of Companies (Santa Clara, CA)
- …in full compliance with the company's Design Control requirements and consistent with FDA , ISO, and MDR requirements. + Define architecture of software system for ... + Initiate and conduct software system code reviews. + Develop documentation per regulatory body guidelines. + Interface with internal regulatory affairs and… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. **_*This position is hybrid*_** **Primary Duties ... concerns regarding data quality and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit… more
- BioLife Plasma Services (Sacramento, CA)
- …gain hands-on experience in operational production, including financial, regulatory , administrative, marketing, quality, facilities, and people management. Gain ... customer service by assisting with production tasks while maintaining strict regulatory compliance and safety standards. + **Develop Leadership and Employee… more
- Teleflex (Pleasanton, CA)
- …health risk assessments, identification of CAPA's, and report generation. * Support regulatory approvals and responses to regulatory questions for existing ... Proven communication skills with cross-functional interaction * Experience with ISO13485, MDD, FDA Quality System Regulations The pay range for this position at… more
- University of Southern California (San Diego, CA)
- …experience is required + Thorough understanding of records management requirements in FDA regulated trials + Ability to build and maintain positive relationships ... + Keep current on TMF Reference Model updates, industry best practices and regulatory requirements + Other duties as assigned USC will consider for employment all… more
- Abbott (Alameda, CA)
- …overall complaint handling process during audits, inspections and assessments by regulatory agencies, globally. Works closely with Commercial Teams and Commercial ... action system. + The incumbent also has a significant interaction with FDA / ISO during inspections. **Required Qualifications** + Bachelor's or Master's degree… more
- Sutter Health (Sunnyvale, CA)
- …adequate stock levels, checking accuracy of pricing, and completing required regulatory documentation. Adheres to all standards, procedures, cleaning protocols, and ... Services (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and the United States Pharmacopeia (USP) organization. Possess solid… more
- Boehringer Ingelheim (Los Angeles, CA)
- …based. + Performs all Company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When ... verbally in a clear, effective and accurate manner in strict compliance with regulatory and other requirements. Attendance / Schedule At least 40 hours per week,… 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