- Actalent (St. Louis, MO)
- …Responsibilities + Execute and oversee sanitation processes in accordance with FDA , USDA, and other regulatory standards. + Work alongside the sanitation ... more
- Canon USA & Affiliates (Thousand Oaks, CA)
- …a strong background in quality management and compliance, with a focus on FDA regulations, CGMP, and various quality systems. This role is critical in maintaining ... 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
- Gilead Sciences, Inc. (Charleston, SC)
- …or therapeutic areas. + Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising ... more
- Amgen (Washington, DC)
- …Actively support regulatory compliance and ensure compliance of submissions to the US FDA + Assist the Global or US Regulatory Lead by preparing supportive ... 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
- Actalent (Santa Clara, CA)
- Description Position Overview In compliance with FDA , European MDD/MDR & ISO regulations, the Quality Systems Specialist will perform work under general supervision. ... more
- Kedplasma (Irving, TX)
- …developed and maintained. Operates within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... more
- Globus Medical, Inc. (San Antonio, TX)
- …accuracy, completeness and compliance with established BBA Standards/procedures, AATB and FDA standards/regulatory guidance and forward to the Medical Director for ... more
- Ultralife Corporation (Newark, NY)
- …personnel to maintain and update Ultralife's quality management system to ISO, FDA QSR, FAA and other applicable requirements. + Coordinate 3rd-party internal audits ... more
- J&J Family of Companies (Raritan, NJ)
- …Engagement: + Lead and host compliance audits and regulatory inspections (eg FDA , IGJ, ANVISA, etc.) + Develop and sustain strong relationships with regulatory ... more
- Endo International (Rochester, MI)
- …that products are developed, manufactured, tested, and packaged according to applicable FDA guidelines, regulations, GXPs, and internal SOPs + Provides counsel on ... more
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