- Grifols Shared Services North America, Inc (Fort Myers, FL)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
- University of Miami (Miami, FL)
- …federal regulations, etc.). Ensures compliance of general and study specific regulatory related processes with institutional SOPs, FDA , NIH, and other ... through study closure as well as the maintenance of regulatory documents to ensure compliance with applicable...regulatory related projects under the direction of the Manager of Regulatory Department Specific Qualifications Education:… more
- Danaher Corporation (Miami, FL)
- …The Regulatory Affairs Intern will gain hands-on experienc e in regulatory strategy, documentation, and compliance within the life sciences industry. You'll ... with global standards. This position reports to the Senior Manager , Regulatory Affairs and is part of...regulatory affairs or quality assurance . Understanding of FDA , EMA, or ICH guidelines . Proficiency in Microsoft… more
- University of Miami (Miami, FL)
- …the primary investigator and project team to assist in responding to queries from regulatory agencies including the FDA . + Tracks proposals and other study ... Translational Research Site is currently seeking a full time Manager , Clinical Research to work in Miami. The ...and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical… more
- Kedplasma (Port Orange, FL)
- …with cGMP, KEDPLASMA DCOP's and other Company standards and protocols to meet regulatory requirements of the FDA , EMEA, Customer Specifications, and other ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...of all DCOPs prior to implementation and confirming DCOP compliance with all applicable statutory and regulatory … more
- University of Miami (Miami, FL)
- …trials as needed. It will monitor recruitment targets and adherence to research compliance and University of Miami policies. The Manager , Clinical Research (A) ... project team to assist in responding to queries from regulatory agencies including the FDA . + Tracks...and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical… more
- United Therapeutics (Tallahassee, FL)
- …communications and/or commercial functions with a Master's Degree + Knowledge of compliance and regulatory framework + Exceptional soft skills including empathy ... communications, and/or commercial functions with a Master's Degree + Knowledge of compliance and regulatory framework + Exceptional soft skills including empathy… more
- University of Miami (Miami, FL)
- …efficient and effective departmental operations, including department quality control and compliance adherence. The Manager , Medical Technologists also manages ... and participates in continuing education activities and events.9. Monitors employee compliance with approved regulatory and departmental guidelines.10. Assists… more
- University of Miami (Miami, FL)
- …activities comply with FDA and GCP guidelines. This includes maintaining regulatory documents when needed and ensuring site compliance with research ... Department of Clinical Translational Research Site is currently seeking a full time Manager , Clinical Research Nursing to work in Miami. The Manager , Clinical… more
- Chewy (Plantation, FL)
- …teams to ensure seamless execution. + Maintain project timelines while ensuring compliance with regulatory , nutritional, and food safety guidelines. + Assess ... developing industry-leading brands? Chewy is seeking an innovative Research & Development Manager to join our dynamic Chewy Private Brands team in Plantation, FL.… more