- Chiesi (Cary, NC)
- …This intern will ensure Chiesi's products are produced and tested under fully FDA compliant systems and processes. This role is instrumental in supporting the ... product portfolio in compliance with technical requirements from existing and new FDA regulations, in accordance with CGMP principles. + Use of statistical… more
- Kelly Services (Jacksonville, FL)
- …You will be instrumental in improving equipment performance, ensuring compliance with FDA , ISO, and GMP standards, and supporting the deployment of innovative ... reliability. + **Regulatory Compliance** Ensure all automation systems comply with FDA regulations, ISO standards, and GMP requirements specific to medical device… more
- Abbott (Sylmar, CA)
- …or improvements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes, ... industries. + Working knowledge of applicable regulations, such as FDA QSR, ISO, MDD, &/or IVDD. + Detailed knowledge...QSR, ISO, MDD, &/or IVDD. + Detailed knowledge of FDA , GMP, ISO 13485, and ISO 14971 Solid communication… more
- University of Michigan (Ann Arbor, MI)
- …Medicare and Medicaid Services (CMS), the US Food and Drug Administration ( FDA ) Good Tissue, and other related accreditation and regulatory agencies. + Proactively ... self-surveys and mock validation surveys, use of Patient Tracer methodology, JC/CMS/ FDA Education and Training, Communication of regulatory readiness and risks as… more
- Oracle (Bismarck, ND)
- …Health is transforming its development and regulatory processes to meet heightened FDA , MDR, and ISO 14155 standards and address ongoing patient safety, compliance, ... or regulated healthcare software sectors. . Extensive experience in FDA , MDR, and ISO 14155 compliance, clinical risk management,...with product lifecycle activities. . Ensure clinical compliance with FDA , MDR, and ISO 14155, acting as the central… more
- AbbVie (Detroit, MI)
- …with regard to schedule management and follow-up skills are required. Knowledge of FDA GMPs. Ability to function in a controlled environment regulated by FDA ... is required. Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations,… more
- PCI Pharma Services (Rockford, IL)
- …lead equipment, process, and cleaning validation efforts to ensure compliance with FDA , ISO 13485, and other applicable regulatory standards. This role is critical ... Ensure all validation activities meet the standards set by FDA 21 CFR Part 820, ISO 13485, and customer...device, pharmaceutical, or biotech industry. + Strong knowledge of FDA regulations, ISO 13485, ISO 14971, and GAMP 5… more
- System One (Diamondhead, MS)
- …that all study activities are performed in compliance with ICH-GCP, FDA , and institutional standards, prioritizing participant safety, data integrity, and regulatory ... or Sub-Investigator in clinical research. + Strong understanding of ICH-GCP, FDA regulations, and clinical research ethics. + Proven leadership in managing… more
- Mentor Technical Group (Carolina, 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 ... in accordance with + Ensure all work complies with FDA , cGMP, safety, and internal quality standards. + Follow...CMMS systems (eg, SAP, Maximo). * Knowledge of GMP, FDA regulations, and cleanroom practices. * Effective communication, teamwork,… more
- Stanford University (Stanford, CA)
- …for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to ... the FDA as required. + Audit operations, including laboratory procedures,...and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical… more