- Solstice Advanced Materials (Buffalo, NY)
- …action implementation. **Responsibilities** * Manage the cGMP Quality System to meet requirements of FDA 21 CFR Part 211 and 21 CFR Part 11. * Final responsibility ... production of drugs or drug excipients *2+ years of experience with practical application of FDA 21 CFR Part 211 and 21 CFR Part 11 in a chemical manufacturing plant… more
- Atlantic Health System (Newton, NJ)
- …per organizational and regulatory standards (eg, Joint Commission, NFPA 99, FDA , ACR). * Maintain accurate records of maintenance, repair, and inspection ... and safety standards, including IEC 60601, IEC 61000, NFPA 99, Joint Commission, FDA , and modality-specific guidelines. * Skilled in the use of advanced test… more
- Lactalis American Group Inc. (Buffalo, NY)
- …requirements. 4. Helps to maintain compliance with workplace and government mandated standards ( FDA , USDA, OSHA, etc.). 5. Responsible for a variety of reports to ... packaging, warehouse, or distribution preferred. Specialized Knowledge * OSHA, Food Safety, FDA , and USDA. * Knowledge of ISO and certifications within the food… more
- Hologic (Newark, DE)
- …of Quality Management Systems (QMS) and electronic documentation systems. + Expertise in FDA 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and other global ... degree in Quality Assurance or a related field. + Prior experience in FDA , Notified Body, ISO, or other regulated manufacturing settings is beneficial. + Proven… more
- Takeda Pharmaceuticals (Lexington, MA)
- …work is done in compliance with IEC 62366 & regulatory body (example, FDA ) expectations. Drive HF/UX initiatives in early stage, development, and LCM projects, ... Human Factors formative and summative studies. + Familiarity with IEC 62366-1/2, FDA HF Guidance, EU MDR usability expectations + Working knowledge of relevant… more
- Abbott (Sylmar, CA)
- …including risk prioritization & mitigation. + Evaluates published Regulatory Agency (eg FDA ) guidance, changes to external standards, actions and audit findings to ... to executive management and staff. + Establishes solid relationship with TUV/BSI/ FDA and other regulatory agencies. Liaison to AQR's External Standards Database,… more
- ThermoFisher Scientific (Florence, SC)
- …Ensure compliance with applicable safety, environmental, and regulatory requirements including FDA , EPA, and OSHA. + Drive continuous improvement through lessons ... a specified Engineering discipline Knowledge of regulatory requirements which include FDA , EPA, and OSHA; engineering project management principles and a knowledge… more
- ConvaTec (NJ)
- …goods entering the country for temporary purposes ensuring regulatory adherence. + Manage the FDA Import for Export (IFE) program from end to end to include all ... and experience working in customs programs globally eg Import for Export ( FDA ), Temporary Imports, Free Trade Agreements, Preferential Origin. + Experience working… more
- University of Pennsylvania (Philadelphia, PA)
- …Penn Profiler trainings). + Adhere to all University of Pennsylvania, GCP, and FDA guidelines. + Perform other duties as assigned which may include assisting with ... Penn Profiler trainings). + Adhere to all University of Pennsylvania, GCP, and FDA guidelines. + Perform other duties as assigned which may include assisting with… more
- Otsuka America Pharmaceutical Inc. (Baton Rouge, LA)
- …the drug, biologic, and device development process, laws, regulations, and guidelines from FDA , EMA, PMDA, ICH, etc. + General knowledge of global regulations for ... 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority are desirable. **Skills and Competencies:** +… more