- ARTIDIS (Houston, TX)
- …or diagnostics environment + Sound knowledge of ISO 13485:2016 and an understanding of FDA Quality System Regulation (21 CFR Part 820) + Hands-on experience in ... driving efficiency, and ensuring that our transformative technology consistently meets FDA requirements and internal quality benchmarks, ultimately supporting… more
- Actalent (Fort Worth, TX)
- …consistent implementation of quality systems. Essential Skills + Medical device quality assurance + FDA regulatory affairs + Process and equipment validation ... Job Title: Quality /Regulatory Manager Job Description The Head of ...recall activities. + Liaise with regulatory agencies such as FDA , Notified Bodies, and Health Canada. + Develop, implement,… more
- Houston Methodist (Houston, TX)
- …and off site. + May assist in the preparation of periodic reports for FDA . ** QUALITY /SAFETY ESSENTIAL FUNCTIONS** + Provide routine updates and reporting to the ... Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on… more
- Abbott (Irving, TX)
- …business competencies that drive results and continuous improvement. + Knowledgeable of FDA , Quality System Regulations (QSR), Medical Device Directive, ISO ... Our 114,000 colleagues serve people in more than 160 countries. **Professional Quality ** **, Validation** **About Abbott** Abbott is a global healthcare leader,… more
- Dow (Houston, TX)
- At a glance Position: FDA Product Regulatory Manager Primary Location:Midland (MI, USA), Michigan, United States of America Additional Locations: Freeport (TX, USA) ... Type:Regular Workplace Type:Remote or Hybrid or Onsite Apply Now (https://dow.wd1.myworkdayjobs.com/ExternalCareers/job/Midland-MI-USA/ FDA -Product-Regulatory-Manager\_R2060938/apply) Return to Job Finder At Dow, we believe… more
- Eliassen Group (Austin, TX)
- …develop corrective actions + Ensure all written materials align with company, quality , and FDA guidelines across all manufacturing components **Experience ... Requirements:** + Ability to manage competing priorities + Overall understanding of process instructions + Life Science Experience + Software Skills Required: MS Platform Suite, Oracle, Coupa + Functional knowledge of Engineering/Maintenance + Maximo or Asset… more
- Veterans Affairs, Veterans Health Administration (Temple, TX)
- …functions and Quality Assurance Knowledgeable of Food and Drug Administration ( FDA ) and Mammography Quality Standards Act (MQSA) Regulations and Requirements ... compliance with all QC and QA requirements as per VHA policy, FDA /MQSA regulations, and ACR standards in mammography, digital breast tomosynthesis, breast… more
- UTMB Health (Galveston, TX)
- …funding agencies to design and execute regulated nonclinical studies compliant with the US FDA GLP regulations or under quality systems that utilize the US ... Scientist II will be assigned as a Study Director, as defined by the US FDA Good Laboratory Practice (GLP) regulations (21CFR58), and will serve as the single point… more
- TreeHouse Foods, Inc. (Northlake, TX)
- …cost-reduction or process improvement projects. + Strong understanding of food safety, quality systems, and regulatory requirements ( FDA , SQF, etc.). + Excellent ... their careers, directly impacting our mission to make high quality , affordable food for our customers, communities, and families....initiative in our Northlake, TX, plant, a manufacturer of quality coffee. Your role will focus on identifying and… more
- Sumitomo Pharma (Austin, TX)
- …other tools used within the group. + Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment ... Duties and Responsibilities** + Defines submission outlines, content, format, and quality requirements for electronic submissions. + Manages the tracking, compiling,… more