- Abbott (Austin, TX)
- …than 500,000 people with diabetes from routine fingersticks. The **Associate Manager of Clinical Trial Reimbursement** is responsible for implementing and managing ... to IDE studies, PM and categorization of A and B categorization by FDA . + Remain current on developments in field(s) of expertise, applicable clinical requirements… more
- Edwards Lifesciences (Austin, TX)
- …SoCRA clinical coordinator/ CRA certification) + Strong understanding of ISO 14155, FDA , and international regulatory requirements + Ability to lead and mentor field ... monitors + Strong understanding of risk-based monitoring, strategies and tools to ensure compliance and data integrity + Ability to resolve conflicts and provide clear guidance + Proficiency in trial management systems (eg RAVE, CTMS, Veeva, & monitoring… more
- Fujifilm (Austin, TX)
- …+ 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** Experience: + 8+ years of progressive… more
- ThermoFisher Scientific (Austin, TX)
- …1 processes and strong knowledge of clinical study operations + Knowledge of FDA regulations and ICH GCP guidelines + Solid computer skills with working knowledge ... of Microsoft Office applications + Good time management and multi-tasking skills + Solid written and verbal communication skills + Strong organizational and prioritization skills with the ability to prioritize workload and adapt to changing study needs +… more
- Sumitomo Pharma (Austin, TX)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- Houston Methodist (Houston, TX)
- …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… more
- Grifols Shared Services North America, Inc (Houston, TX)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and...is performed. + Under the guidance of the Center Manager and/or the Assistant Manager , assure facility… more
- Grifols Shared Services North America, Inc (Odessa, TX)
- …of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. **Primary ... Responsibilities:** + Serves as acting leader in the absence of the Center Manager as assigned. Maintains the ability to perform any/all tasks within the plasma… more
- Compass Group, North America (Houston, TX)
- …17,000 professional food service team members. **Job Summary** **The Quality Assurance Manager ** is responsible for development and maintenance of all QA programs, ... meeting USDA, FDA and customer requirements and ensuring the quality and...prerequisite food safety standards are met according to USDA, FDA , FSIS, FSMA and corporate requirements. + Must have… more
- L3Harris (Greenville, TX)
- …functions as POC for inquiries from US governmental agencies such as Customs, FDA and/or Census through data gathering and corrective action execution as instructed ... by the Global Trade Compliance Manager . Essential Functions: + Ensure regulatory compliance with all...Participating Government Agencies (PGA's) including but not limited to FDA , ATF, EPA, Census, FAA and others as needed… more