- Grifols Shared Services North America, Inc (Chicago, IL)
- …of technical guidelines to assure execution of regulatory strategies and requirements . This is a fully remote role. **Primary responsibilities:** + Develops ... for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory … more
- GE HealthCare (Chicago, IL)
- …direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, ... direction for the ARC business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance,… more
- United Therapeutics (Springfield, IL)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... staff, vendors, contractors & other UT employees supporting PV activities. **Minimum Requirements ** + Education and Experience requirements : + Bachelor's degree… more
- Sumitomo Pharma (Springfield, IL)
- …+ Strong understanding of pharmacovigilance regulations and drug safety reporting requirements + Skills in signal detection, risk assessment, and safety data ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- Rush University Medical Center (Chicago, IL)
- …position. Offers may vary depending on the circumstances of each case. **Summary:** The Manager of Quality, Bone Marrow Transplant is serves as a member of the Bone ... cellular therapy. * Experience with FACT, CAP, AABB and/or FDA inspections. * Experience in quality assessment, process improvement...is intended to describe the general content of and requirements for the performance of this job. It is… more
- US Tech Solutions (North Chicago, IL)
- …and maintain **complaint files,** in compliance with regulations established by the FDA and international regulatory bodies, and submit safety reports to the ... FDA and international Competent Authorities. + In addition will...conduct their work activities in compliance with all internal requirements and with all applicable regulatory requirements ,… more
- Grifols Shared Services North America, Inc (Wood River, IL)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and...is performed. * Under the guidance of the Center Manager and/or the Assistant Manager , assure facility… more
- Kedplasma (Chicago, IL)
- …+ Knowledge of FDA and EU regulations and standards preferred. **Physical Requirements ** Work is primarily light in nature, with exerting up to 25lbs of force ... center personnel under the direction of the Quality Assurance Manager . Escalates any non-compliance that affects donor safety or...of EU Guidance on Good Manufacturing Practice (GMP) and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has… more
- Kedplasma (Springfield, IL)
- …with SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, customer specifications and other regulatory bodies ... compliant plasma collections under the direction of the Center Manager . Operates within the scope of EU Guidance on...scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has… more
- CSL Plasma (Chicago, IL)
- **The Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance ... with CSL Operating Procedures, as well as all applicable local, state, federal requirements . This role will ensure compliance to training needs, SOPs, processes and… more