- Abbott (Sylmar, CA)
- …US readiness program, including risk prioritization & mitigation. + Evaluates published Regulatory Agency (eg FDA ) guidance, changes to external standards, ... compliance to executive management and staff. + Establishes solid relationship with TUV/BSI/ FDA and other regulatory agencies. Liaison to AQR's External… more
- Abbott (Pleasanton, CA)
- …work environment. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... Management System compliance to internal policies, applicable standards and external regulatory requirements. **What You'll Work On** + The incumbent defines and… more
- Stanford University (Stanford, CA)
- …for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug ... and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge… more
- Parexel (Sacramento, CA)
- …Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory documentation for FDA , EMA, and Health Canada (IND, NDA, DMF) * ... experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory ...Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure… more
- Stanford University (Stanford, CA)
- …for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug ... applications to the FDA as required. + Audit operations, including laboratory procedures,...regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical… more
- ABM Industries (Irvine, CA)
- …to the development, implementation and effectiveness of Quality Management System per ISO, FDA , and other regulatory agencies. Understands and is aware of the ... of Quality system requirements, as well as internal and regulatory audits. Ensure compliance with all Facilities and Quality...Remain knowledgeable of current federal and international regulations, including FDA 21CFR part 820, FDA 21CFR part… more
- Abbott (Alameda, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... the requirements of the quality system, as well as FDA , ISO, MDD, CDR, MHLW, and other regulations applicable...industry + Min 8 years auditing per ISO and/or FDA standards. + Knowledge of MDD, CMDR, MHLW, TGA,… more
- Abbott (Alameda, CA)
- …Quality Management System (QMS), Environmental Management System (EMS), and other regulatory requirements. + Ensure compliance with FDA regulations, ... not limited to: + Complaints trending and summaries + FDA Medical Device Reporting (MDR) trending and summaries +...complaint investigations in a regulated environment. + Knowledge of FDA Quality System Regulations (QSR) and ISO 13485 standards.… more
- Kelly Services (South San Francisco, CA)
- …methods. + Ensure analytical testing is conducted in full compliance with regulatory (ICH, FDA ) and internal quality requirements. + Provide technical ... and chromatographic tools (eg, HPLC-UV, LC-MS). + Comprehensive knowledge of ICH, FDA , and related regulatory requirements for method validation, method… more
- Abbott (Sylmar, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... systems are developed, validated and maintained in compliance with regulatory and business procedures. As a global leader in...GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla. + Knowledge of FDA 21 CFR part 820, 21 CFR part 11,… more