- Stanford University (Stanford, CA)
- …multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal ... for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug… more
- US Tech Solutions (San Bruno, CA)
- …Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (eg, FDA , Notified Bodies, etc.), and regulatory ... History File, and align with stakeholders. + Collaborate with Quality , Regulatory , Engineering, and UX teams to...Experience with medical device development standards eg ISO 13485, FDA 21 CFR 820 + Experience working with products… more
- Cedars-Sinai (Los Angeles, CA)
- …pediatric populations preferred. + Experience with clinical trial budgeting and regulatory for FDA -regulated therapeutics preferred. **About Us** Cedars-Sinai is ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). **Primary Duties & Responsibilities** +… more
- Oracle (Sacramento, CA)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- Stanford University (Stanford, CA)
- …+ Experience executing randomized controlled trial treatment studies. + Experience with FDA regulatory procedures and reporting. + Demonstrated experience with ... conduct impactful clinical research with a focus on high quality and efficiency. We are seeking candidates with excellent...regulatory filing. Ensure compliance with HIPAA, GCP, and FDA regulations as applicable. + Own operational readiness for… more
- Oracle (Sacramento, CA)
- …for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Excellent cross-functional communication and documentation skills. Preferred: . Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k),… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …developing and executing the global GxP training strategy to ensure compliance with regulatory requirements and foster a strong quality culture across the ... lead the global GxP training strategy aligned with corporate quality objectives and regulatory standards. + Establish...training content is accurate, current, and aligned with global regulatory requirements ( FDA , EMA, ICH). **Compliance &… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …measures to improve production methods, equipment performance, facility layout, and quality of product. 17. Provide scientific and/or technical advice and counsel ... regarding projects as needed. 18. Maintain current knowledge of regulatory and industry standards. 19. Generate thorough written reports, when required, that… more
- VTI Life Sciences (San Diego, CA)
- …those systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, ... and preliminary problem diagnosis. + Provide all services in accordance with FDA cGxP guidelines and regulations. QUALIFICATIONS: + Bachelor's degree or higher in… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …applicable QC Microbiology Standard Operating Procedures (SOP) to ensure compliance with FDA guidelines, QSR, cGMP, and other regulatory standards and drive ... procedural improvements. + Support internal and external audits (eg, FDA , Corporate Quality Assessments) by ensuring compliance with procedures, guidelines, and … more