- Fujifilm (College Station, TX)
- …Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and ... Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data… more
- ARTIDIS (Houston, TX)
- …and release of received goods + Execute all local Quality Management activities in compliance with FDA Requirements + Ensure compliance assurance and ... efficiency, and ensuring that our transformative technology consistently meets FDA requirements and internal quality benchmarks, ultimately supporting superior… more
- ZOLL Medical Corporation (Dallas, TX)
- …and internal training + Knowledge of industry specific cybersecurity frameworks and regulatory requirements such as FDA Pre and Post-market Guidance on ... with product teams across ZOLL to ensure the security, privacy, and compliance of medical devices, patient data, and intellectual property through secure coding… more
- United Therapeutics (Houston, TX)
- …the US Food and Drug Administration ( FDA ) and, as appropriate, ex/US regulatory agencies + Strong knowledge of cGMP compliance and Quality **Preferred ... . The Director, DPF Site Operations role is pivotal in maintaining regulatory compliance , upholding the highest quality standards, and driving operational… more
- Kedplasma (Houston, TX)
- …with cGMP, KEDPLASMA DCOP's and other Company standards and protocols to meet regulatory requirements of the FDA , EMEA, Customer Specifications, and other ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...of all DCOPs prior to implementation and confirming DCOP compliance with all applicable statutory and regulatory … more
- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …planning, execution, and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** ... trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible… more
- Abbott (Plano, TX)
- …validation, calibration, and QMS improvement initiatives. + Maintain compliance with applicable regulatory standards (eg, ISO 13485, FDA 21 CFR Part 820) and ... will lead a team of quality professionals to ensure compliance with internal procedures, regulatory requirements, and...+ Strong knowledge of quality systems, inspection techniques, and regulatory requirements (ISO 13485, FDA ). + Strong… more
- Kedplasma (Pharr, TX)
- …center activities with SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, customer specifications and other ... Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make… more
- Fujifilm (College Station, TX)
- …and implement microbiological quality control procedures to ensure compliance with FDA , EMA, and other relevant regulatory guidelines. + **Data Integrity** : ... in maintaining a contamination-free environment, support our product pipeline, and ensure regulatory compliance . **Company Overview** The work we do at FUJIFILM… more
- Cardinal Health (Austin, TX)
- …IDNs, hospitals, physician offices, etc.), strategic sourcing, marketing, regulatory / compliance and contract manufacturing. **_Responsibilities_** + Demonstrate ... collaborate with subject matter experts from other departments, especially the Legal, Regulatory Counsel and Compliance teams + Demonstrate knowledge of general… more