- Veterans Affairs, Veterans Health Administration (San Antonio, TX)
- …SOPs for the assigned specialty area(s), ensuring they meet or exceed regulatory , accreditation, and professional standards. Modifies or adapts new methods and ... in assigned area(s) meets accrediting agency (AABB, CAP, TJC, CLIA, FDA ,) standards and identifies areas for improvement. Reviews accreditation checklists,… more
- Houston Methodist (Houston, TX)
- …exceptional patient care and adheres to standards and guidelines established by regulatory agencies and Houston Methodist to ensure optimal patient safety and ... and prepares with Principal Investigator, Institutional Review Board (IRB) and regulatory documents for submission assuring compliance with local and federal … more
- Wolters Kluwer (Coppell, TX)
- …success managing product line projects, including risk mitigation, regulatory awareness, translating customer needs into business requirements, stakeholder ... and tracking success metrics. * Leverage knowledge of US healthcare government and regulatory published drug information and policy data sources (CMS, FDA , etc.)… more
- Deloitte (Dallas, TX)
- …technologies like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory authoring tool(s) ... ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in.../EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years… more
- Houston Methodist (Houston, TX)
- …of the department's major projects/grants. Assists in writing SOP's and other regulatory requirement documentation. + Maintains and provides in-services for the HM ... documentation needed from project conception to completion as well as maintaining regulatory and milestone (financial) records as required for each study. +… more
- Houston Methodist (Houston, TX)
- …data and advising sponsors as to how best to present data considering regulatory agency requirements. + Prepares moderately complex documents and sections of ... regulatory submissions and contributes scientific knowledge and analytical skills...research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387… more
- MD Anderson Cancer Center (Houston, TX)
- …stakeholders as the medical technology / equipment SME, in terms of regulatory requirements, compliance measures and technology sustenance / maintenance post project ... Device Governance with emphasis on Cybersecurity measures, SCORE (Huron Group) program, FDA GRC / Info-Sec Medical Device Classification and continuous efforts to… more
- Baylor Scott & White Health (Round Rock, TX)
- …with national standards and regulating bodies such as Joint Commission, CDC, OSHA, FDA , and HHS + Provides consultation to providers, staff, clinicians, and nursing ... educational programs for employees. These programs maintain compliance with regulatory agencies. They increase employee awareness of nosocomial infections. They… more
- Abbott (Irving, TX)
- …Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements. + Coordinate validation activities with other ... Quality System are developed, validated, and maintained in compliance with regulatory and corporate requirements. + Contributes to defining and timely achievement… more
- Abbott (Irving, TX)
- …analysis, and hands-on service support to ensure product excellence and regulatory compliance. **Product & Process Development** + Independently lead and oversee ... + Recommend and implement Design Control procedures in accordance with FDA guidelines **Engineering Analysis & Risk Mitigation** + Perform experimental, empirical,… more