- Bio-Techne (Austin, TX)
- …Quality Management System in alignment with international quality and regulatory standards. **Key Responsibilities:** Provides support ensuring compliance ... capabilities and unique technologies ranging from biomarker discovery to international regulatory expertise and the ability to launch innovative products as both… more
- ARTIDIS (Houston, TX)
- …protocols, and ensure the highest standards of data quality, reproducibility, and regulatory compliance . You will work closely with research teams, clinical ... study reports, work instructions (WIs), and test plans in compliance with FDA regulations and ISO 13485...analysis. + Familiar with medical device operations, ISO 13485, FDA guidelines, CE Marking, and international regulatory … more
- Abbott (Plano, TX)
- …protocol development, execution, and documentation. + Ensure compliance with applicable regulatory standards (eg, ISO 13485, FDA 21 CFR Part 820) and ... improvements. + Solid understanding of quality systems, inspection techniques, and regulatory requirements (ISO 13485, FDA ). + Excellent communication,… more
- Merck (Austin, TX)
- …including response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies. The successful candidate for ... aimed at answering customer and industry questions, monitoring protocol compliance , and summarizing results from post-approval marketing support trials specific… more
- ARTIDIS (Houston, TX)
- …or service attains the highest caliber in terms of quality standards and regulatory compliance . This job requires 100% on-site availability and 50% traveling ... reports, work instructions (WIs), and test plans to ensure compliance with FDA regulations and ISO quality...Device Knowledge: Proficient in medical device operations, ISO 13485, FDA guidelines, CE Marking, and international regulatory … more
- BioBridge Global (San Antonio, TX)
- …and product related. Assist and develop testing procedures according to organizational and regulatory (NMDP, AABB, FACT, ISO, FDA , and cGMP) standards. Assist ... advanced therapies. Leveraging its showcase facility designed to be compliant with FDA , EMEA, and PMDA production requirements, BBG Advanced Therapies focuses on… 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 ... deliverable(s) expectations. Clearly explains any project stage challenges or hurdles. Compliance /Regulations Maintain regulatory / compliance aspects of… more
- Sumitomo Pharma (Austin, TX)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties… more
- Biomat USA, Inc. (Odessa, TX)
- …the daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations ... staff during assigned shifts. + Learns and maintains thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration… more
- Kedplasma (San Antonio, TX)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...needed. + Records any required documentation accurately and in compliance with company SOPs. + Maintains data integrity and… more