- Houston Methodist (Houston, TX)
- …procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations ... have prior work experience with **FDA Form 1571** (Investigational New Drug Application (IND) submissions, expanded access protocol submissions under an existing… more
- Grifols Shared Services North America, Inc (Texarkana, TX)
- …thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, ... Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures. + Supervise donor selection, plasma collection and all manufacturing records to… more
- MD Anderson Cancer Center (Houston, TX)
- …pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration) * Complete forms and comply with ... institutional, state, and/or federal regulations for study initiation, conduct, and termination * Coordinates and sends outgoing material and correspondence to institutional, state, and/or federal agencies *Data Management Organization and Analysis of Clinical… more
- Abbott (Irving, TX)
- …layouts to support document control and tool release. + 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. **Required Qualifications** + Bachelor's in electrical… more
- Abbott (Houston, TX)
- …Maintains a safe and professional work environment. + 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. **EDUCATION AND EXPERIENCE YOU'LL BRING** + Bachelors… more
- CSL Plasma (Laredo, TX)
- …Director. **The 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… more
- Ascension Health (Austin, TX)
- …+ Assure proposed clinical research study protocols are in compliance with the Food and Drug Administration (FDA) regulations through review and approval by ... the Institutional Review Board (IRB). **Requirements** Licensure / Certification / Registration: + Licensed Registered Nurse credentialed from the Texas Board of Nursing required. + Certification specializing in Research Professional credentialed from the… more
- Fujifilm (Austin, TX)
- …Adhere and enforce all safety policies. + 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.… more
- Fujifilm (Austin, TX)
- …as assigned 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
- Fujifilm (Austin, TX)
- …+ Participates in professional organizations. + 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.… more