- Imperative Care (Campbell, CA)
- …external bodies (Notified Body, FDA , etc.) and internal audits to maintain regulatory compliance . + Oversee quality and compliance issues, actively ... objectives. + Lead the design assurance team and ensure compliance with domestic and international regulatory standards (eg, FDA , CE marking, etc.). +… more
- Stanford University (Stanford, CA)
- …study specific milestones, and invoice sponsors according to study contract. + Ensure regulatory compliance . Regularly inspect study document to ensure ongoing ... regulatory compliance . + Work with principal investigator to ensure Investigational...executing randomized controlled trial treatment studies. + Experience with FDA regulatory procedures and reporting. + Demonstrated… more
- Abbott (San Diego, CA)
- …oversees the design, development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They play a crucial role in ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Hologic (San Diego, CA)
- …and process product complaints in compliance with Hologic SOPs and applicable regulatory requirements ( FDA , ISO, EU MDR). + Conduct initial assessments and ... a key role in ensuring the safety, effectiveness, and regulatory compliance of medical devices after release....Regulatory Reporting + Support preparation and submission of regulatory reports (eg, FDA MDR, EU Vigilance,… more
- Sumitomo Pharma (Sacramento, CA)
- …and achieve goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, ... Interactions: + Prepare and present clinical data to regulatory agencies ( FDA , EMA) during IND submissions,...clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with… more
- Abbott (Sylmar, CA)
- …for software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. Work requires the ... for multiple projects. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- Abbott (Alameda, CA)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... Staff Quality Auditor will serve as experts for the compliance team with respect to observation tracking, auditing, regulations...the requirements of the quality system, as well as FDA , ISO, MDD, CDR, MHLW, and other regulations applicable… more
- VTI Life Sciences (San Diego, CA)
- …systems used in regulated environments are validated in compliance with industry standards, regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data ... Engineering, Life Sciences, or related discipline. + 5+ years of relevant FDA -regulated industry experience. + Expertise in regulatory requirements and guidance,… more
- CSL Plasma (Fairfield, CA)
- …role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and ... facility compliance with CSL procedures and policies, cGMP, OHSA, FDA , and other regulations, as applicable, and develop center responses for deficiencies.… more
- Praxair, Inc - a Linde Company (Fresno, CA)
- …- $112,200 yearly (commensurate with experience) What you will be doing: + Provide FDA regulatory and Quality systems support to assigned locations within the ... manufacturing and warehousing locations in addition, assess source material vendors for compliance to POIS and regulatory requirements for the manufacturing of… more