- Cedars-Sinai (Beverly Hills, CA)
- …research setting. + Familiarity with clinical research operations, including regulatory compliance , study coordination, and staff development. **Preferred ... of study assignments within the group. + Supervise research staff and ensure compliance with federal and local regulations, including FDA and IRB requirements.… more
- Ascendis Pharma (Palo Alto, CA)
- …and Preventative action (CAPA) as applicable. + Supports with the oversight of regulatory and departmental compliance by ensuring timely processing of ICSRs in ... departmental SOPs, Work Instruction etc. as applicable and ensure compliance with regulatory guidelines and regulations. +...+ Experience with MedDRA coding and global safety reporting regulatory requirements. + Working knowledge of FDA … more
- Abbott (Sylmar, CA)
- …CI/CD pipelines that support traceability, automated testing, and documentation for regulatory compliance . + Help design, implement, and deploy cloud-based ... ensure our systems are fast, reliable, and compliant with FDA and ISO standards. **What You'll Work On** As...Experience with automated testing and static code analysis tools. Regulatory & Compliance + Experience working in… more
- Sutter Health (Oakland, CA)
- …patient care. The role involves a fast-paced environment with an emphasis on compliance and regulatory standards in patient care and medication management. ... liaise with pharmaceutical manufacturers and assistance programs. + **Accreditation & Compliance :** Ensure compliance with accreditation standards (eg, URAC,… more
- Sutter Health (Oakland, CA)
- …patient care. The role involves a fast-paced environment with an emphasis on compliance and regulatory standards in patient care and medication management. ... liaise with pharmaceutical manufacturers and assistance programs. + **Accreditation & Compliance :** Ensure compliance with accreditation standards (eg, URAC,… more
- Ascendis Pharma (Palo Alto, CA)
- … Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits + ... of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global safety regulations. + Ability to… more
- Stanford Health Care (Palo Alto, CA)
- …collaboration between providers and coordination of community resources. + Ensures compliance with legal, regulatory and clinical policies and procedures. ... Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved...not FDA -approved or are used for a non- FDA -approved indication (off-label use) require a patient-specific order in… more
- J&J Family of Companies (Santa Clara, CA)
- …implement various processes by working closely with research/development, operations, regulatory , and quality teams. **Essential Job Functions** + Develop product(s) ... for manufacturing in full compliance with the company's Design Control requirements and consistent...with the company's Design Control requirements and consistent with FDA , ISO, and MDR requirements + Prototype and develop… more
- Wacker Chemical (San Diego, CA)
- …engineering software and tools, as well as Microsoft Office Suite. + Knowledge of regulatory requirements, including FDA , GMP, and ISO standards. + Requires good ... contractors to ensure equipment and systems meet performance and compliance requirements. + Stay up to date with industry...related field) + 5-8 years of experience in a FDA and GMP regulated industry. + ISO 7 &… more
- Abbott (Pomona, CA)
- …development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA , and other regulatory agencies. + Responsible for exhibiting ... validated rooms and equipment. **WHAT YOU'LL DO** + Applies basic understanding of FDA , ISO and cGMP theories and principles. + Contribute to Group's objectives by… more