- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... plan, execute, and supervise study oversight activities with guidance from Quality , Strategic Development Clinical Operations, and clinical execution team. Oversee… more
- Jabil (Hunt Valley, MD)
- …of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic ... is maintained across all systems and processes, supporting product quality , patient safety, and regulatory compliance This...System Validation (CSV) program and supervise CSV associates. Ensure compliance with cGMP, FDA , EMA (Annex 1),… more
- University of Utah (Salt Lake City, UT)
- …**Responsibilities** **Essential Job Responsibilities** **Research Coordination:** + Oversees compliance to study protocols: manages quality control, ... Principal Investigator in identifying and accomplishing study objectives. Incumbent maintains compliance to a host of department, university, and governing agency… more
- Medtronic (Minneapolis, MN)
- …The company strives to provide products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers ... resolve potential regulatory issues and questions from regulatory agencies. + Prepare FDA , European, and Canadian submissions for product changes to ensure timely… more
- Mentor Technical Group (Juncos, PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With… more
- Mentor Technical Group (PR)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With… more
- Biomat USA, Inc. (Eugene, OR)
- …management. Manages the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and ... staffing/hours per labor efficiency standards/cost per liter (CPL) targets and Quality key performance indicators (KPI) goals. + Create appropriate organizational… more
- Grifols Shared Services North America, Inc (Lithonia, GA)
- …management. Manages the daily operations of the center, supervising operations and quality control, and ensuring compliance with all applicable policies and ... staffing/hours per labor efficiency standards/cost per liter (CPL) targets and Quality key performance indicators (KPI) goals. + Create appropriate organizational… more
- Cardinal Health (Mansfield, MA)
- …manufacturing or testing environment, preferred. + Strong knowledge of ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other ... transfer, preferred. + Experience with investigations of Out of Specification (OOS) per FDA guidelines a plus. + Experience with quality management systems (eg,… more
- Edgewell Personal Care (Allendale, NJ)
- …Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell's brand portfolio. Responsible for assessing, interpreting, ... and maintained across the organization, as well as ongoing and future regulatory compliance planning and proof of cGMP. Lead the design of regulatory strategy… more