- Teleflex (Pleasanton, CA)
- …skills. * Familiarity with ISO 13485, ISO 62304, ISO 14971, IEC 82304-1, MDD, and FDA QSR. * Experience developing mechatronic products with IEC 60601 is a plus. * ... the marketplace. * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …plus 5 years of proven technical/project management and leadership experience in a FDA , USDA environment OR Masters degree plus 3 years of proven technical/project ... management and leadership experience in a FDA , USDA environment. + Depending on the area of assignment, directly related experience or a combination of directly… more
- Hologic (Newark, DE)
- …quality management systems (QMS) and regulatory standards (eg, GMP, GLP, ISO, FDA , Six Sigma). + Strong knowledge of manufacturing, sterilization, and cleanroom ... junior engineers, and present findings to stakeholders. + Working knowledge of FDA and ISO regulations governing medical devices is highly beneficial. **Behaviors**… more
- University of Southern California (Los Angeles, CA)
- …ongoing assessment of protocol deviations and violations.4. Participates in NCI, FDA and pharmaceutical audits and is knowledgeable of their regulations, especially ... are recorded correctly and accurately. If Serious Adverse Events are experienced, follows FDA guidelines for prompt reporting within 24 hours. e. If requested will… more
- Charles River Laboratories (Northridge, CA)
- …supported the development of 100% of the current commercially available FDA -approved immunocellular therapies. Our mission is to provide a best-in-class portfolio ... worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your… more
- Abbott (Sylmar, CA)
- …requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... and issue-tracking tools such as GIT, Jira, Subversion, ClearQuest, Doors, Bugzilla. + Knowledge of FDA 21 CFR part 820, 21 CFR part 11, GMP, IEEE 1012, IEC 62304… more
- Mount Sinai Health System (New York, NY)
- …* Ensures proper purchasing practices and documentation in compliance with DEA, FDA , state board regulations, and hospital policies. * Supports 340B inventory ... Returns & Shortages * Manages product recalls and returns per vendor or FDA guidance; ensures proper documentation and communication. * Coordinates with vendors to… more
- Stanford Health Care (Palo Alto, CA)
- …Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA -approved indication (off-label use) ... require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room. The RN First Assistant directly assists the surgeon and practices under the supervision of the… more
- Access Dubuque (Dubuque, IA)
- …Ad hoc member of the Food Safety Team. Comprehends HACCP principles and FDA Food Safety Program requirements. External certification in HACCP and FSMA PCQI training. ... 2. Experience working with any of the US government agencies such as FDA , USDA/APHIS with food and/or pet food/animal feed, Qualified PCQI. Experience with Halal… 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