- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …understanding of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory ... etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for… 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 ... skills, self-starter a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and communication skills with… more
- Kelsey-Seybold Clinic (Houston, TX)
- …training approved by the ARRT and 25 supervised exams to meet the minimum initial FDA & TMB requirements for mammographers Mammo Tech II - High School diploma or ... hours mammography training approved by the ARRT to meet the minimum initial FDA & TMB requirements for mammographers 2-years' experience in mammography or 1-year KSC… more
- Abbott (Austin, TX)
- …System (QMS) responsibility for TPM ensuring robust compliance and alignment with FDA , ISO, cGMP, etc + Lead continuous improvement initiatives within the QMS ... to meet the skills and responsibilities of the position. + Substantial knowledge of FDA and ISO Quality System Requirements and other applicable US Code of Federal… more
- Actalent (Grand Prairie, TX)
- …international markets. Key Responsibilities + Ensure laboratory practices comply with FDA , Health Canada, and international regulatory requirements + Maintain and ... Cosmetics *REQUIRED* + Experience with regulatory frameworks, label review, FDA registration, and documentation standards + Excellent communication and… more
- BioBridge Global (San Antonio, TX)
- …advanced therapies. Leveraging its showcase facility designed to be compliant with FDA , EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on ... Visio and PowerPoint. Must obtain a working knowledge and understanding of FDA regulations and current Good Manufacturing Practices (cGMPs). Must obtain a working… more
- ARTIDIS (Houston, TX)
- …study reports, work instructions (WIs), and test plans in compliance with FDA regulations and ISO 13485 standards. + Provide on-site support and troubleshooting ... quantitative data analysis. + Familiar with medical device operations, ISO 13485, FDA guidelines, CE Marking, and international regulatory frameworks. + Skilled in… more
- Abbott (Plano, TX)
- …and documentation. + Ensure compliance with applicable regulatory standards (eg, ISO 13485, FDA 21 CFR Part 820) and internal quality procedures. + Participate in ... quality systems, inspection techniques, and regulatory requirements (ISO 13485, FDA ). + Excellent communication, collaboration, and problem-solving skills. Apply Now… more
- Biomat USA, Inc. (Odessa, TX)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. + Attends… more
- Abbott (Plano, TX)
- …initiatives. + Maintain compliance with applicable regulatory standards (eg, ISO 13485, FDA 21 CFR Part 820) and internal quality procedures. + Drive standardization ... of quality systems, inspection techniques, and regulatory requirements (ISO 13485, FDA ). + Strong experience in quality data analytics, including statistical… more