- Integra LifeSciences (Plainsboro, NJ)
- …management. This job is expected to work onsite. Must have working knowledge of US Food and Drug Administration regulations, ISO 13485, and other applicable ... + Author or revise Standard Operating Procedures (SOPs). + Participates in FDA inspections, ISO certifications, surveillance audits, and customer audits. + Interpret… more
- University of Southern California (Los Angeles, CA)
- …and cell therapy. Demonstrated passion for solving complex scientific issues. Experience with Food and Drug Administration regulations and clinical trials. ... resolve technical issues in a timely manner. Knowledge of regulatory requirements and guidelines (eg, FDA , EMA) related to cGMP. REQ20160212 Posted Date: 03/10/2025 more
- Merck (Augusta, ME)
- …agencies worldwide, especially those conducted by key authorities such as the USA Food and Drug Administration , European Medicines Agency, UK Medicines ... may be assigned as Point of Contact for a specific area of regulations (eg FDA , EMA, NMPA, etc.). As such, the COM is responsible for monitoring, interpreting and… more
- United Therapeutics (Research Triangle Park, NC)
- …and reports, Investigator's Brochures, and safety documents that may be submitted to the Food and Drug Administration and other global health authorities for ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
- Guidehouse (St. Louis, MO)
- …are currently searching for a Quality Assurance Specialist to provide support to the US Food & Drug Administration in the following locations: St. Louis, MO, ... **:** + Experience with ISO 17025 certification. + Familiarity with the FDA regulatory submissions and product reviews. + Knowledge of continuous improvement… more
- Fresquez Companies (Albuquerque, NM)
- …Safety Conscious, Cleanliness + Strong knowledge and understanding of company and FDA standards, processes, and procedures. + Detail oriented. + Excellent listening ... Skills: Restaurant experience is preferred. Knowledge and understanding of relevant food safety and sanitation laws, principles, procedures, and practices. Work… more
- University of Southern California (Los Angeles, CA)
- …and cell therapy. Demonstrated passion for solving complex scientific issues. Experience with Food and Drug Administration regulations and clinical trials. ... issues in a timely manner. Knowledge of regulatory requirements and guidelines (eg, FDA , EMA) related to cGMP. REQ20165292 Posted Date: 07/30/2025 - Thru date -… more
- Integra LifeSciences (Plainsboro, NJ)
- …of medical products are in compliance with company policies and procedures, US. Food and Drug Administration Regulations, ISO 9001, ISO 13485:2016 ... and standards, and internal Standard Operating Procedures + Provide support in FDA inspections, ISO audits and customer audits at the CMC facility **DESIRED… more
- Fresquez Companies (Albuquerque, NM)
- …Mechanical Ability, Initiative + Strong knowledge and understanding of company and FDA standards, processes and procedures. + Detail oriented. + Excellent listening ... cleaning services or related experience. Knowledge and understanding of relevant food safety and sanitation laws, principles, procedures, and practices. Ability to… more