- University of Miami (Miami, FL)
- …to assist in responding to queries from regulatory agencies including the FDA . + Tracks proposals and other study relevant documentation through signature/approval ... and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best Practices. + Establishes and… more
- University of Miami (Miami, FL)
- …SOPs are in compliance with relevant rules and regulations such as the FDA , CLIA, state testing requirements, Joint Commission, etc., managing FDA reportable ... events, errors and deviations, performing self-inspection, and auditing, educating clinical team, reviewing and investigating safety events. + Meets with QA Medical Director and Laboratory Director for final assessment of quality data, outliers, and corrective… more
- BioLife Plasma Services (Tallahassee, FL)
- …or Bachelor's Degree + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated or high-volume retail environment + ... Excellent interpersonal, organizational, technical, and leadership skills **About BioLife Plasma Services** Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll… more
- BioLife Plasma Services (Gainesville, FL)
- …(in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years in ... a clinical or hospital setting What Takeda can offer you: Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you… more
- Pfizer (Tampa, FL)
- …and AI-driven translation solutions while ensuring compliance with Pfizer policies and FDA , EMA, and MDR or any other applicable regulations. + **Implement workflow ... automation and migration to a TMS, plus AI and MT technologies** **where appropriate** to enhance efficiency while maintaining accuracy and regulatory adherence. + **Support with overseeing translation quality and regulatory compliance** by working with Pfizer… more
- Actalent (Miami, FL)
- …new product development of medical devices. + Working knowledge of US FDA and international regulatory requirements. + Experience with supplier quality management ... (approval, audit, and incoming inspection). + ASQ certification preferred. + Experience working with statistical analysis software including Minitab preferred Job Type & Location This is a Contract to Hire position based out of MIAMI, Florida. Pay and Benefits… more
- Danaher Corporation (Deland, FL)
- …+ Ensure compliance with applicable standards and regulatory requirements (eg, ISO, FDA Food & Beverage, PEC, ECHA, etc.). + Oversee internal and external ... audits, including regulatory inspections and customer audits. + Collaborate with cross-functional teams including Manufacturing, Operations, R&D, Supply Chain, and Regulatory Affairs. + Develop and manage the regional quality resource and capacity planning. +… more
- Cardinal Health (Deland, FL)
- …and perform repairs on associated departmental equipment in conformance to FDA , GMP's, ISO 13485 standards and finished product specifications. Minimize scrap ... generation from processes and promote workplace safety. Provide process information to management so production equipment may be optimized and/or process corrected. Assist with training of personnel to perform various functions within each assigned area.… more
- Amgen (Miami, FL)
- …+ Orphan or Rare disease experience. + Familiarity with HIPAA guidelines and FDA requirements. + Familiarity with and Adherence to internal and OIG Compliance ... guidelines a must + Ability to handle difficult patient cases and resolve hurdles. + Ability to work in team environment and manage communication with case Liaisons and sales reps. + Ability to respond immediately when necessary (within 24 hours) to prevent… more
- Medtronic (Orlando, FL)
- …in a manner that adheres to ethics & compliance guidelines and FDA requirements Communication: + Work with internal functions (marketing, customer service, finance, ... etc.) to meet targets (ie. Inventory management audits, customer service protocols, etc.) + Communicate market intelligence/competitor activity promptly, including potential sales leads, information regarding product pricing or account activity to District… more
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