- Takeda Pharmaceuticals (Boston, MA)
- …of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports ... more
- Catalent Pharma Solutions (Harmans, MD)
- …of life-enhancing and life-saving treatments for patients annually. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located ... more
- Kedplasma (Slidell, LA)
- …within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. Additionally, responsible for providing independent medical judgment and ... more
- Community Health Systems (Birmingham, AL)
- …maintaining compliance with state, federal, and regulatory standards, including FDA /MQSA and ACR requirements. **Essential Functions** + Performs mammography imaging ... more
- Charles River Laboratories (Memphis, TN)
- …related field with two (2) years of experience in cGMP environment with knowledge of the FDA or EU regulations - OR - * Associates degree in science or related field ... more
- ThermoFisher Scientific (Richmond, VA)
- …position requires strong leadership, expertise in regulatory compliance (eg, CLIA, CAP, FDA , ISO 15189), and the ability to drive continuous improvement throughout ... more
- Philips (Bothell, WA)
- …user evaluation and create the usability engineering file, in compliance with the FDA guidance and IEC62366-1. **You're the right fit if:** + You've acquired 5+ ... more
- Actalent (Phoenix, AZ)
- …Principal Investigator and in compliance with study protocols, GCP, and FDA regulations. Administer prescribed study and concomitant medications. Perform phlebotomy ... more
- Actalent (St. Paul, MN)
- …Ensure qualification and validation processes comply with regulatory requirements (eg, FDA , OTC monographs) and internal quality standards. + Support quality ... more
- Actalent (St. Louis, MO)
- …Responsibilities + Execute and oversee sanitation processes in accordance with FDA , USDA, and other regulatory standards. + Work alongside the sanitation ... more
- Actalent (San Diego, CA)
- …Instructions, assist management with continuous improvement, stay current on applicable FDA , ISO, and other industry requirements, create training materials, conduct ... more
- Actalent (Allentown, PA)
- …oversight, and approval. The ideal candidate must be familiar with ISO13485, FDA , and GMP regulations. Responsibilities + Manage and control quality documentation. + ... more
- Abbott (Minnetonka, MN)
- …needs to be filed with various global regulatory agencies (eg, FDA , European Competent Authorities) and sends reports within required timeframes.Prepares customer ... more
- Actalent (Lake Mills, IA)
- …and attend necessary training sessions. Responsibilities + Assist with USDA/ FDA requirements, paperwork, and floor walkthroughs. + Conduct pre-operational ... more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …governmental inter-agency activities at international, federal and state level (eg EMA, FDA , CDC, NABP) on personalized medicines areas of common interest to USP. ... more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …might look like: + Responsible for the strategic company guidance on FDA and global regulatory requirements (affairs and CMC) for investigational and commercial ... more
- UCLA Health (Los Angeles, CA)
- …study protocol and applicable regulations such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). ... more
- Actalent (Vernon Hills, IL)
- …of leadership experience in Quality Operations. + 10+ years of experience in FDA regulated or ISO certified environments. + Strong mathematical skills, knowledge of ... more
- Medtronic (Santa Rosa, CA)
- …compliance with Medtronic internal policies and quality system processes, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations. ... more
- MD Anderson Cancer Center (Houston, TX)
- …that the laboratory in which he/she is working complies with the CAP, JCAHO, FDA , Medicare, and CLIA regulations for accreditation. . Must be able to relate quality ... more
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