- Fotona (Irving, TX)
- …and building operational resilience in a dynamic, fast-paced environment. Key Leadership Responsibilities: Regulatory & FDA Compliance Strategy + Serve as ... medical device, life sciences, or healthcare sector. + Deep expertise in FDA compliance , inspection readiness, and regulatory liaison. + Demonstrated success… more
- Honeywell (Houston, TX)
- …transfer streamlining, batch execution and recipe management, quality management systems, regulatory compliance (GMP, FDA , EMA), manufacturing analytics, ... critical challenges including technology transfer, batch execution, quality management, regulatory compliance , and operational efficiency. **Key Responsibilities**… more
- BioBridge Global (San Antonio, TX)
- …and maintenance of controlled documents and record retention. Must maintain familiarity of regulatory /quality compliance , to include FDA , EU, ISO, GHM, cGMP, ... _QualTex Laboratories is an FDA -registered and CLIA-certified organization that provides state-of-the-art, high volume capacity donor screening and biological… more
- Houston Methodist (Houston, TX)
- …service focus and application of positive language principles + Familiar with quality, compliance and FDA regulatory requirements for Good Laboratory ... to work in a highly regulated radiopharmaceutical drug manufacturing facility in compliance with FDA cGMP guidance. **PEOPLE ESSENTIAL FUNCTIONS** + Provides… more
- Houston Methodist (Houston, TX)
- …**SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH and ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible...International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across… more
- Houston Methodist (Houston, TX)
- …ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH and ... At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible...International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across… more
- UTMB Health (Galveston, TX)
- …procedures. + Provide internal and external communications, scientific expertise, and regulatory compliance expertise; able to interact and communicate with ... FDA GLP regulations as a reference standard. The Regulatory Scientist I / II may also function as...interpersonal skills. + Knowledge of and ability to interpret regulatory requirements and perform duties in compliance … more
- Sumitomo Pharma (Austin, TX)
- …+ Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA . + Serve as internal regulatory expert on FDA regulations, ... encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and… more
- Merck (Austin, TX)
- …and compliance across all documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and ... Skills:** Biological Sciences, Clinical Immunology, Communication, Immunology, Immunotherapy, International Regulatory Compliance , Leadership, Motivation Management, Pharmaceutical … more
- Stryker (Flower Mound, TX)
- The **Director, Regulatory Operations** leads regulatory compliance for the **Endoscopy Division** and provides strategic leadership to cross-functional ... the office. Relocation support can be provided. + Leads organization engaged in regulatory compliance such as Complaint Handling, Reporting and Field Actions and… more