- Dana-Farber Cancer Institute (Brookline, MA)
- …Event reports, to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + ... Ensure various regulatory reporting required are met; Study Sponsor, FDA , IRB etc. **Key Stakeholder Interfacing** + Establishing and...or all of the following areas: DFCI, DF/HCC, ICH/GCP, FDA policy / guidance / regulation; an understanding of… more
- Globus Medical, Inc. (Audubon, PA)
- …for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This ... position entails development of FDA submissions, requires working knowledge of products under review...in building working relationships with internal teams while following FDA 21 CFR regulations. **Essential Functions:** + Partners with… more
- CVS Health (Blue Bell, PA)
- …actively monitor the US public health in collaboration with Food and Drug Administration ( FDA ), academic institutions, and other health insurance ... medical chart review validations, and pragmatic research using the FDA Sentinel Common Data Model (SCDM), Sentinel and Distributed...the findings to internal team and clients including the FDA . The role is expected to work collaboratively in… more
- Houston Methodist (Houston, TX)
- …by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the ... Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases… more
- Abbott (Casa Grande, AZ)
- …and professional work environment. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... and plant grounds. The purpose of the job is to implement food safety, sanitation, and regulatory compliance policies, procedures and training. **Working at… more
- Primo Brands (Katy, TX)
- …products to ensure regulatory compliance with the applicable Food and Drug Administration ( FDA ), State, Local, International Bottled Water Association ... to become a Preventive Controls Qualified Individual (PCQI) as part of the FDA Food Safety Modernization Act (FSMA) requirements. + Ability to become a Safe… more
- Primo Brands (Portland, OR)
- …products to ensure regulatory compliance with the applicable Food and Drug Administration ( FDA ), State, Local, International Bottled Water Association ... to become a Preventive Controls Qualified Individual (PCQI) as part of the FDA Food Safety Modernization Act (FSMA) requirements. + Ability to become a Safe… more
- Abbott (Temecula, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... contractors, and vendors. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating… more
- HonorHealth (AZ)
- …Health and Human Services (DHHS) regulations: 45 CFR 46, and Food and Drug Administration ( FDA ) regulations: Title 21 Code of Federal Regulations. This ... Review Board and assures compliance with IRB guidelines and FDA regulations. In accordance with (45 CFR 46.101-409) the...by the Department of Health and Human Services, the Food and Drug Administration and… more
- IQVIA (Durham, NC)
- …standard operating procedures (SOPs), Good Clinical Practice (GCP), Food & Drug Administration ( FDA ) regulations, quality improvement initiatives, and ... validation strategy to improve quality & compliance, ensures adherence to global regulations ( FDA , MHRA, EMA, GDPR) throughout system life cycle + First line of… more