- Mount Sinai Health System (New York, NY)
- …research or a related field + Experience working with sponsors, FDA and consortiums preferred. **Responsibilities** + Protocol development: Work with investigators ... development. + Obtains IND# for the clinical trials through correspondence with the FDA , and submission of paperwork necessary to obtain an IND#. + Collaborates with… more
- Jabil (Monument, CO)
- …IM&TE and process control equipment used throughout facility in compliance with FDA /ISO regulations and established procedures. + Ensures timely submission of IM&TE. ... in a Pharmaceutical or Medical Device environment + Experience with industry related FDA , QSR, cGMP, ISO Regulations + Ability to manage multiple tasks in a… more
- Vitalief (Philadelphia, PA)
- …data collection/entry. + Manage regulatory binders, IRB submissions, and compliance with FDA , IRB, and GCP guidelines. + Monitor safety events, prepare reports, and ... (academic/institutional site experience preferred). + Strong knowledge of GCP, FDA , and IRB regulations. + Experience in patient recruitment/retention, IRB… more
- ADM (Decatur, IL)
- …results in a timely matter. + Support and comply to all applicable FDA , GMP, USP, Biosafety, and OSHA requirements. + Follow laboratory standards and maintain ... applications, and software). + Maintain awareness and adhere to all applicable FDA , GMP, USP, Biosafety, OSHA and employer standards and guidelines. + Follow… more
- Lundbeck (Bothell, WA)
- …and analytical techniques used in downstream processing. + Ensure adherence to FDA , EMA, ICH guidelines, and other relevant regulatory requirements. + Support ... and troubleshooting downstream processes. + Familiarity with regulatory guidelines ( FDA , EMA, ICH) and quality standards. **Preferred Education, Experience, and… more
- Caris Life Sciences (Phoenix, AZ)
- …Responsibilities** + Maintain regulatory compliance to all applicable regulatory requirements ( FDA , CLIA, NYS, ISO, CAP, etc.) + Maintains exceptional quality ... science, or medical technology from an accredited institution. + Experience in FDA regulated industries. + Ability to work in a fast-paced, deadline driven… more
- Terumo Medical Corporation (Elkton, MD)
- …of medical device manufacturing industry regulations, and quality control (ISO Standards, FDA Regulations, etc.) + Proficiency in Microsoft Office. + Knowledge of ... of medical device manufacturing industry regulations, and quality control (ISO Standards, FDA Regulations, etc.) + Proficiency in Microsoft Office. + Knowledge of… more
- Biomat USA, Inc. (Huntsville, AL)
- …state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), ... state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA),… more
- Abbott (Plymouth, MN)
- …160 countries. **MAIN PURPOSE OF THE ROLE** Manufactures products in an FDA regulated environment. May operate basic equipment for reagent filling, packaging, and ... basic manufacturing operations and demonstrating the ability to work in an FDA regulated environment in a timely manner. b). Executing assigned work activities… more
- Cedars-Sinai (Beverly Hills, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary Duties and Responsibilities + ... with all federal and local agencies including the Food and Drug Administration ( FDA and local Institutional Review Board. + Maintains research practices using Good… more