- Boehringer Ingelheim (St. Joseph, MO)
- …US requirements in development activities. The manager will be responsible for FDA meetings and submissions for their assigned projects. This role is responsible ... for linking regulatory affairs information to internal and external stakeholders ( FDA ) to ensure sufficient and efficient communication through activities such as… more
- Abbott (San Diego, CA)
- …risk assessments and contribute to risk mitigation strategies aligned with FDA and international cybersecurity guidance. + Implementation of security risk controls ... ComplieswithU.S. FoodandDrugAdministration ( FDA )regulations,otherregulatoryrequirements, Companypolicies,operatingprocedures,processes,andtaskassignments.… more
- UTMB Health (Galveston, TX)
- …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 ... and execute regulated nonclinical studies compliant with the US FDA GLP regulations or under quality systems that utilize...regulations or under quality systems that utilize the US FDA GLP regulations as a reference standard. The Regulatory… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Prepares and submits regulatory documentation that may include IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory ... agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA), etc. + Prepares, maintains and organizes Regulatory files for… more
- MD Anderson Cancer Center (Houston, TX)
- …that the laboratory in which he/she is working complies with the CAP, JCAHO, FDA , Medicare, and CLIA regulations for accreditation. * Must be able to relate quality ... implemented, and that laboratory complies with the CAP, JCAHO, FDA , Medicare and CLIA regulations for accreditation. * Must...* Must assure compliance with standards of CAP, JCAHO, FDA , Medicare, and CLIA. * Must give theoretical guidance… more
- Philips (Washington, DC)
- …if:** + You've acquired a minimum of 10+ years' experience in FDA Regulations, Global Regulatory Affairs, Policies and Standards within the Medical Device/Technology ... industry or Health Authority ( FDA ), with proven experience in Strategic Regulatory program leadership. + You have a demonstrable history of success in a regulatory… more
- Dana-Farber Cancer Institute (Boston, MA)
- …unit will support interventional studies to the IRB as well as assist with FDA submissions and IND management. Reporting to the CTIP Associate Director for the ... to the appropriate regulatory agencies including the Food and Drug Administration ( FDA ), Office of Biotechnology Activities (OBA) + Support the maintenance of the… more
- Omnicell (Cranberry Township, PA)
- …Lead external audits and regulatory inspections, ensuring full compliance with ISO, FDA , and other relevant regulatory bodies. + Develop and implement advanced ... knowledge of QMS processes and regulatory standards (ISO 13485, FDA , etc.) + Demonstrated ability to lead large-scale projects,...a regulated environment (ie ISO 9001, ISO 13485 or FDA regulated) + Experience working with QMS Training (Learning… more
- Iowa Department of Administrative Services (State Of Iowa, IA)
- …or manufacturing facility; experience applying food safety regulations such as the FDA Food Code or Good Manufacturing Practices; or a combination of both ... facility; experience applying food safety regulations such as the FDA Food Code or Good Manufacturing Practices; or a...facility; experience applying food safety regulations such as the FDA Food Code or Good Manufacturing Practices; or a… more
- BASF (Bishop, TX)
- …Practices (GMP) and general housekeeping guidelines along with rules for FDA manufacturing plant + Package active pharmaceutical ingredients and chemical ... at least 6 months of packaging experience in an FDA or ISO regulated environment. + Demonstrate flexibility and...+ Preferrably possess good understanding of ISO, GMP, and FDA guidelines, and operating PLC experience. **Create your own… more