- Stanford Health Care (Palo Alto, CA)
- …Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off-label use) ... require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room. The RN First Assistant directly assists the surgeon and practices under the supervision of the… more
- Dairy Farmers of America (Riverside, CA)
- …and test results - Ensure compliance with regulatory requirements, such as FDA regulations and HACCP guidelines - Assist in the development and implementation ... skills to maintain accurate documentation of quality records - Understanding of FDA regulations and HACCP guidelines If you are a dedicated professional with… more
- Taiho Oncology (Pleasanton, CA)
- …direct reports. + In-depth knowledge of MedDRA, global labeling requirements ( FDA , EMA, ICH), and safety database management. + Experience with configuration ... Argus). + In-depth knowledge of relevant Food and Drug Administration ( FDA ), European Union (EU) and International Conference on Harmonization (ICH) guidelines,… more
- Stanford Health Care (Palo Alto, CA)
- …the consent process to ensure it is performed in compliance with institutional, FDA , IRB, clinical trial sponsor and other applicable regulations. + Oversees and ... guidelines, policies and procedures when providing care. Ensures adherence to GCP, ICH, FDA and other regulatory agencies in the conduct of clinical research. +… more
- WuXi AppTec (Middletown, DE)
- …stability program timelines. Regulatory Compliance * Ensure all analytical testing meets FDA , EMA, and ICH regulatory requirements for drug product QC. * Maintain ... forms. * Strong understanding of ICH, USP <61>, <62>, <85>, <1116>, EP, JP, FDA , and EMA regulatory requirements for drug product QC. * Demonstrated ability to… more
- Terumo Neuro (Aliso Viejo, CA)
- …submission activities focused on US/EU/Canada and for ensuring compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral ... a week 4. Strong technical writing skills as evidence by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada… more
- LGC Group (Milford, MA)
- …LGC Proficiency Testing a global leader in PT schemes. We operate FDA -registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland ... who is experienced with a working knowledge of quality system requirements, including FDA QSR/cGMP, ISO 13485 and ISO 14971. The successful candidate will have a… more
- BeOne Medicines (Pennington, NJ)
- …and release of materials, intermediates, and finished products under FDA /EU regulations, applicable international regulations, and BeOne processes and procedures. ... Bachelor of Science degree and 5+ years of experience in an FDA -regulated biotechnology, pharmaceutical company with progressive levels of responsibility required. +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …reports. + Ensure compliance with design control procedures, medical device regulations (eg, FDA 21 CFR Part 820, ISO 13485), and company policies. + Contribute to ... actions. Compliance & Audits: + Support internal and external audits (eg, FDA , ISO) by providing documentation and technical expertise related to design quality.… more
- ADM (Decatur, IL)
- …all products meet international regulatory standards and food safety guidelines (eg, FDA , EFSA, Codex Alimentarius, etc.). + Drive a culture of continuous ... and food safety experience is required. + Knowledge and experience working with FDA , USDA and international regulatory agencies. + Knowledge and experience with GFSI… more