- Abbott (Sylmar, CA)
- …Follow approved Design Control procedures for software development in accordance with FDA guidelines. + Contributes to and supports root-cause analysis of failures. ... more
- Stanford University (Stanford, CA)
- …for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to ... more
- Neotech (Fremont, CA)
- …equipment calibration and maintenance to it is compliant to customer requirements, FDA regulations and ISO specifications. * Ensure the production floor is compliant ... more
- Fortive Corporation (Everett, WA)
- …regulatory teams to plan and execute testing activities, ensuring compliance with FDA , ISO, and other relevant standards. You will work within cross-functional teams ... more
- Owens & Minor (Littleton, CO)
- …patient care forms and required billing forms. + Completes all required DOT, FDA , and other required regulatory paperwork per company guidelines and instruction. + ... more
- University of Colorado (Aurora, CO)
- …and submit accreditation application documentation for appropriate regulatory agencies, including FDA (GMP and GTP), ASHI, CAP, AABB, AATB, and FACT. Approve ... more
- Astrix Technology (Rancho Dominguez, CA)
- …and discrepancies as neede + Ensure all documentation complies with applicable FDA , SQF, and other regulatory standards + Assist with identifying and resolving ... more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. The ... more
- LCI-Lawinger Consulting (Minneapolis, MN)
- …throughout the product development lifecycle, ensuring compliance with regulatory standards ( FDA , ISO, etc.). + Review and approve design documentation, including ... more
- Unither Pharmaceuticals (Rochester, NY)
- …necessary controls and mitigation methods. Develops, writes, and executes qualification protocols ensuring FDA 21 CFR part 11 and Annex 11 compliance as well as ... more
- BeiGene (Hopewell, NJ)
- …for clinical and commercial phase biologics products in accordance to FDA /EU regulations, applicable International Regulations and BeiGene processes and procedures. ... more
- Cambrex High Point (Charles City, IA)
- …(cGMPs). + Establish quality strategies to ensure cGMP compliance with US FDA , EMA, and other health authority regulations and expectations. Interface directly with ... more
- University of Utah (Salt Lake City, UT)
- …intake databases (REDCap) including electronic consent. 6. Prepares, submits and maintains IRB , FDA , NCI , NIH , NSF and/or other regulatory documents and research ... more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This ... more
- Envista Holdings Corporation (Thousand Oaks, CA)
- …process discipline required in a Class 1 and Class II FDA -regulated manufacturing environment. Their organizational, communication, and leadership skills are second ... more
- University of Miami (Miami, FL)
- …New Drug (IND) submissions to the Food and Drug Administration ( FDA ), and amendments. This position involves close collaborations with principal investigators ... more
- US Tech Solutions (Irvine, CA)
- …material, stability testing, test method transfer). * Strong working knowledge of cGMP, FDA and EMA GMP regulation and ICH guidance documents. Familiarity with CDC ... more
- Ophthalmic Consultants of Boston (Weymouth, MA)
- …Performance Requirements: + Working knowledge of theory and application of FDA and ICH Good Clinical Practice (GCP) guidelines. + Excellent organizational, ... more
- University of Miami (Miami, FL)
- …general and study specific regulatory related processes with institutional + SOPs, FDA , NIH, and other applicable regulations. + Adheres to University and unit-level ... more
- Katecho (Des Moines, IA)
- …System (QMS), ensuring alignment with both internal and external standards, including FDA , EMA, ICH, and GMP. + Regulatory Compliance: Ensure compliance with ... more