- University of Colorado (Aurora, CO)
- …**Preferred Qualifications:** + Experience working with Institutional Review Boards or OHRP/ FDA regulations regarding human subject research. + Certified IRB Manager ... Office for Human Research Protections (OHRP) and Food and Drug Administration ( FDA ) regulations for human subject research. + Knowledge of higher educational and/or… more
- Dentsply Sirona (Charlotte, NC)
- …for medical devices that are sufficient for ISO 14155, EU MDR and FDA . + Preparation and submission of clinical study documentation to Independent Ethics ... regulations related to conduct of human clinical studies (eg ISO 14155, EU MDR, FDA , GDPR, Declaration of Helsinki, Good Clinical Practice (GCP) and EU AI Act). +… more
- Charles River Laboratories (Northridge, CA)
- …such as Standard Operation Procedure manuals, Current Good Manufacturing Practices, FDA and AABB regulations. **Job Qualifications** * High school diploma or ... supported the development of 100% of the current commercially available FDA -approved immunocellular therapies. Our mission is to provide a best-in-class portfolio… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …understanding of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory ... etc.) in pharmaceutical or healthcare related industry. Experience with FDA or other health authority interactions desirable. **Competencies** **Accountability for… more
- GRAIL (Durham, NC)
- …validation protocols and procedures in compliance with CLIA, CAP, NYS, ISO 13485, FDA , and other applicable standards. + Provide scientific and technical support to ... clinical laboratory regulatory standards, including CLIA, CAP, NYS, ISO 13485, and FDA . + Experience with or understanding of reagent manufacturing and alternative… more
- Cedars-Sinai (Los Angeles, CA)
- …source documents to ensure that research is being conducted according to IRB, FDA , OHRP, HIPAA and other agency guidelines. + Maintains high quality, up-to-date ... regulatory files (CITI and other training documents, financial disclosures, FDA forms, CVs, medical licenses, etc.) for research studies. + Completes appropriate IRB… more
- Bausch + Lomb (Tampa, FL)
- …and new infrastructure. + Ensure compliance with applicable regulatory standards, including FDA cGMP guidelines, EU GMP Annex 1, and other relevant regulations ... equipment start-up, and aseptic manufacturing operations. + Strong background with FDA and EU regulations. + Project management training or certification. +… more
- Church & Dwight Co., Inc. (Lakewood, NJ)
- …+ Follow batch sheet instructions and sign off on each step of the process - FDA Required. + Obtain samples from each batch and submit to the Quality Department for ... Minimum one year experience as a Compounder/Batch maker in a fast-paced manufacturing environment. FDA environment a plus. + Experience with WMS a plus. + Must clear… more
- Church & Dwight Co., Inc. (Lakewood, NJ)
- …customer audits, in addition to ensuring the plant maintains compliance to FDA Regulations, Global Food Safety Initiative (GFSI) Standards and customer requirements. ... managing multiple priorities in a face paced environment* Knowledge of cGMPs and FDA Regulations pertaining to Manufacturing of OTC Drug Products (21 CFR 211)*… more
- Curia (Albuquerque, NM)
- …reliability. + Ensure compliance with all relevant regulatory and safety requirements ( FDA , EMA, OSHA, etc.). + Manage and coordinate vendor support for equipment ... device industry a plus. + Strong understanding of GMP, cGMP, and FDA regulations preferred. + Hands-on experience with packaging lines (vials, labeling, cartoning,… more