- CSL Plasma (Temple, TX)
- …Role** * Serves as the primary physician for reporting to the Food and Drug Administration , in such capacity provides medical oversight in compliance with ... applicable Federal and State regulations including the applicable sections of Title 21 of the Code of Federal Regulations, and monitors medical compliance of the center. * Either serves as or delegates to another appropriate physician the duties of "laboratory… more
- Fujifilm (Austin, TX)
- …Manager, High Field Operations. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO ... 13485 standard requirements and all other applicable laws, regulations, and standards. **Qualifications** Experience: + Minimum five (5) years previous service-related experience. + Demonstrated ability at operating installation tools and test equipment. +… more
- Abbott (Plano, TX)
- …in Non-Conforming Material Review system. *Complies with US Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, ... operating procedures, processes, and task assignments. *Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. *Support all Company initiatives as identified by management and in… more
- MD Anderson Cancer Center (Houston, TX)
- …technique where applicable. Reviews medications and allergies. Follows the five rights of drug administration . F. Ensures work areas and equipment is safe, ... clean, organized and appropriate supplies are available for the procedures and checklists are completed (includes emergency supplies). G. During system failure, performs down time procedures and immediately reports to supervisor for reassignment of duties. H.… more
- Fujifilm (Austin, TX)
- …by the Area Service Manager. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... standard requirements and all other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** +… more
- Houston Methodist (Houston, TX)
- …developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the ... International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating… more
- Fujifilm (Austin, TX)
- …other duties as assigned. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 ... standard requirements and all other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** + BA/BS… more
- Houston Methodist (Houston, TX)
- …+ Conducts internal inspections and audits to ensure compliance with Federal Drug Administration (FDA) regulations and cGMP Core policies and procedures. ... **FINANCE ESSENTIAL FUNCTIONS** + Uses resources efficiently; does not waste supplies. Self-motivated to independently manage time effectively and prioritize daily tasks **GROWTH/INNOVATION ESSENTIAL FUNCTIONS** + Participates with the Quality Assurance… more
- Fujifilm (Austin, TX)
- …in approach and communications. + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO ... 13485 standard requirements and all other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. Key Performance… more
- United Therapeutics (Houston, TX)
- …or biotech production facility + Experience interfacing with the US Food and Drug Administration (FDA) and, as appropriate, ex/US regulatory agencies + Strong ... knowledge of cGMP compliance and Quality **Preferred Qualifications** + Master's degree in life science, engineering, or another related field + Experience and understanding of Xenotransplantation and/or organ transplantation **Job Location & Travel** This… more