- Stanford Health Care (Palo Alto, CA)
- …has been in treating B-cell lymphoma, where CAR T-cell therapy has become an FDA -approved standard of care. We are now expanding our efforts to develop cell ... Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -...not FDA -approved or are used for a non- FDA - approved indication (off-label use) require a patient-specific order… more
- Sumitomo Pharma (Sacramento, CA)
- …relevant external advertising & promotional regulations or codes of practice (eg, FDA regulations, PhRMA guidelines, etc.) and are consistent with company guiding ... with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on ...FDA . + Serve as internal regulatory expert on FDA regulations, guidance and enforcement trends governing the promotion… more
- Hologic (San Diego, CA)
- …in supporting quality activities related to Design Control efforts in accordance with FDA , ISO, and other IVD regulations. You will also support the company's ... quality system activities and design comply with the FDA 's Quality System Regulations (QSRs), ISO 13485, and applicable...knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as… more
- Abbott (Alameda, CA)
- …to assess compliance to the requirements of the quality system, as well as FDA , ISO, MDD, CDR, MHLW, and other regulations applicable to the CATD Quality System. ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more
- Abbott (Alameda, CA)
- …future actions. + Complies with US Food and Drug Administration ( FDA ) and international regulations, other regulatory requirements, Company policies, operating ... 5 of those years related to the preparation of FDA submissions (PMA, IDE, 510(k)) for Class I, II,...related discipline. + Advanced level degree + Experience with FDA , ANVISA, TGA, NMPA, EU and other international medical… more
- Terumo Neuro (Aliso Viejo, CA)
- …coordinating clinical research activities in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations, and MicroVention SOPs. Job duties: + As ... with the protocol, GCP, MicroVention SOPs, and all applicable regulations (eg, FDA ). + Support budget and contract negotiations with clinical sites. + Assist… more
- Abbott (Alameda, CA)
- …approved design control procedures for software development in accordance with FDA guidelines. + Lead software development projects, providing mentoring and ... + Solid knowledge of regulations for medical device development, (EN460001, ISO13485, FDA ) is desirable. + Experience in model based design (UML or SysML),… more
- Owens & Minor (Van Nuys, CA)
- …preventive maintenance on vehicles is performed on a timely basis according to DOT, FDA and Joint Commission. + Responds to emergency delivery calls as needed and on ... Training Program. + Must meet job-related requirements to comply with DOT, FDA and Joint Commissions regulations. **SKILLS, KNOWLEDGE AND ABILITIES** + Business… more
- Abbott (Sylmar, CA)
- …Lead data generation, validation protocols, and submission strategies for new FDA 510(k) AI-based SaMD modules. Support international regulatory submissions. + ... least 5 years in healthcare or medical devices. + Proven track record of FDA -cleared AI tools and SaMD development. + Strong understanding of regulatory pathways and… more
- Owens & Minor (Sacramento, CA)
- …**Valid driver's license.** + **Must meet job-related requirements to comply with DOT, FDA and standards of accrediting body.** + **Current MVR must meet company ... **PREFERRED QUALIFICATIONS** **Education and/or Experience** + Knowledge of DOT and FDA regulations + Knowledge of Home Healthcare industry + Two years… more
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