- Deloitte (Raleigh, NC)
- …Compliance: Ensure all solutions and processes meet global regulatory requirements (eg, FDA , EMA, PMDA) and industry best practices. + Data Analysis & Reporting: ... (Word, Excel, Power Point) + Knowledge of global regulations and guidelines such as ICH, FDA , EMA, PMDA, etc. + Ability to travel 50%, on average, based on the work… more
- Stryker (Durham, NC)
- …particularly in vulnerability management. + Knowledge of medical device regulations (eg, US FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, ... FDA cybersecurity guidance). 115,600.00 to 245,800.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant… more
- Astellas Pharma (Sanford, NC)
- …to job responsibilities. + Assist in the preparation and hosting of regulatory (eg FDA , EMA, DHHS, etc.) inspections as needed. + May perform other quality assurance ... relevant quality experience in a biologics manufacturing facility. + Strong understanding of FDA , EMA, and ICH regulations and guidelines, as well as industry best… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …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
- UNC Health Care (Hendersonville, NC)
- …clinical care for patients enrolled in a clinical trial while adhering to all FDA , OHRP and GCP guidelines and regulations. This position has a central role in ... ongoing consent process is performed and documented in compliance with FDA , International Conference on Harmonization Good Clinical Practice (GCP), institutional,… more
- Herbalife (Winston Salem, NC)
- …AND BACKGROUND REQUIRED TO BE SUCCESSFUL: Strong understanding of GMPs, FDA documentation requirements, and GDP. Proficiency in document management systems and ... Minimum of 5 years in document control or quality assurance roles within an FDA -regulated industry. At least 1 year of supervisory or team lead experience preferred.… more
- FST Technical Services (Holly Springs, NC)
- …project drawings, specifications, codes, and regulatory requirements (eg, ASME, cGMP, FDA , ISO). Quality Oversight + Oversee and verify inspection results, ... managing budgets, schedules, and multi-disciplinary teams. + Familiarity with cGMP, FDA , and ASME B31.3 or equivalent standards. Certifications (Preferred) + PMP,… more
- Lilly (Concord, NC)
- …Solid understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and/or OSHA. + Excellence in; interpersonal, electronic, written, and ... in manufacturing/operations with 4+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + Aseptic filling, single use… more
- University of North Carolina- Chapel Hill (Chapel Hill, NC)
- …Lineberger Comprehensive Cancer Center. The position is part of UNC's new NIH / FDA -funded Center for Tobacco Regulatory Science and Health Equity. We are looking ... broad theme of the UNC Center is building the science for effective FDA regulation of and communication about tobacco products disproportionately used by priority… more
- Owens & Minor (Morrisville, NC)
- …preventive maintenance on vehicles is performed on a timely basis according to DOT, FDA and Joint Commission. + Responds to emergency delivery calls as needed and on ... Training Program. + Must meet job-related requirements to comply with DOT, FDA and Joint Commissions regulations. **SKILLS, KNOWLEDGE AND ABILITIES** + Business… more