- Abbott (Atlanta, GA)
- …and other regulatory requirements. * Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... experience and demonstrated use of Quality tools/methodologies. + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971 Solid communication and interpersonal… more
- Abbott (Sylmar, CA)
- …and other regulatory requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... 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
- Envista Holdings Corporation (Quakertown, PA)
- …+ Ensure that the company's products comply with the US Food and Drug Administration ( FDA ), local and state agencies and global health authority ... of experience in progressive Quality Assurance role and exposure to FDA regulations/ISO 13485 requirements. + Experience with statistical software packages such… more
- Abbott (Atlanta, GA)
- …teams and senior management. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, ... etc) + Strong knowledge of a development process consistent with ISO, FDA design control standards or requirements, and risk management practices. + Demonstrated… more
- Abbott (Pleasanton, CA)
- …Charts, PFMEAs, and Control Plans. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, ... experience and demonstrated use of Quality tools/methodologies + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971 + Solid communication and interpersonal… more
- United Therapeutics (Houston, TX)
- …or biotech production facility + Experience interfacing with the US Food and Drug Administration ( FDA ) and, as appropriate, ex/US regulatory agencies + ... their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial… more
- Cedars-Sinai (Los Angeles, CA)
- …Ensures compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains ... study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and… more
- J&J Family of Companies (Santa Clara, CA)
- …containment and counter measures. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements (ISO), Company ... outcome. + Experience working in regulated product and manufacturing environments (ISO, FDA , cGMP). + Knowledge of and compliance with applicable Quality System… more
- Cedars-Sinai (Los Angeles, CA)
- …compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. *Maintains research ... study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and… more
- Geisinger (Danville, PA)
- …meets the American College of Radiology (ACR) and United States Food and Drug Administration ( FDA ) definition of a qualified medical physicist (QMP). ... + Supports inspections/audits from regulatory/recommending bodies including TJC, PA DEP, FDA , ACR, and DOH. + Supports/oversees use of advanced medical imaging… more