- Cordis (Irvine, CA)
- …and maintain the microbiology strategy in alignment with combination product regulatory requirements ( FDA , EU MDR, ISO). + Establish, build, mentor and manage a team ... in relation to microbiology, this includes PMA direct support, FDA inspections as the microbiology SME for a combination...environments. + Strong working knowledge of GMP, ISO 13485, FDA QSR, EU MDR, and combination product regulations. +… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …insights for decision-making. Additionally, it manages regulatory communications such as FDA responses, drives continuous improvement across the quality system, and ... and collaborative decision making + Draft and coordinate responses to FDA warning letters, field action inquiries, and other regulatory correspondence. Ensure… more
- Boehringer Ingelheim (Fresno, CA)
- …System. + Performs all Company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. + ... Previous account management experience. * Various regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company...and knowledge of territory. * Regulations such as EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company… more
- Oracle (Sacramento, CA)
- …Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring ... Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). ..... Experience supporting regulatory submissions or audits (EU MDR, FDA 510(k), etc.). . Experience working with AI-driven medical… more
- Cedars-Sinai (Los Angeles, CA)
- …study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and ... with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- Compass Group, North America (Escondido, CA)
- …is responsible for development and maintenance of all QA programs, meeting USDA, FDA and customer requirements and ensuring the quality and safety of supplied goods. ... and all other prerequisite food safety standards are met according to USDA, FDA , FSIS, FSMA and corporate requirements. + Must have extensive knowledge of the… 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
- Oracle (Sacramento, CA)
- …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
- 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
- Grifols Shared Services North America, Inc (San Diego, CA)
- …strategies, preparing and submitting complex pre-market and post-market applications to FDA , EU Notified Bodies, and other international authorities, and managing ... Prepares and files complex pre-market and post-market regulatory submissions with the US FDA , Notified Bodies in the EU and other international regulatory bodies, as… more