- J&J Family of Companies (Santa Clara, CA)
- …lab operations are compliant to company policies and regulatory standards + Support regulatory reports for FDA , IEC, UL, et al. + Responsible for ensuring ... developments related to company's products + Interface with R&D, Regulatory , Quality, IT and other cross-functional stakeholders to ensure...the area of algorithm and acoustic tools development (in compliance with IEC and FDA standards) +… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …facility layout, and quality of product. + Maintain a quality presence to ensure compliance with all regulatory requirements. + Maintain current knowledge of ... for out-of-specification results or out-of-procedure events. + Participate in regulatory and internal inspections/audits including providing written responses as… more
- Abbott (Sylmar, CA)
- …+ Lead data generation, validation protocols, and submission strategies for new FDA 510(k) AI-based SaMD modules. Support international regulatory submissions. + ... Ensure AI solutions comply with relevant regulatory standards and collaborate with Regulatory Affairs...innovation team; foster a culture of excellence, collaboration, and compliance . Coach and mentor team members on performance and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …oversight and completion of assigned tasks. + Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables. ... and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements. +...the drug development process and GVP, including global regulations ( FDA , EMA, ICH) and their application to cross-functional drug… more
- Amgen (Thousand Oaks, CA)
- …Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues. + Serve as the primary CDM representative ... of resources **Preferred Qualifications:** + Experience within clinical data management, regulatory compliance , and strategic leadership within a pharmaceutical,… more
- Astrix Technology (Rancho Dominguez, CA)
- …errors and discrepancies as neede + Ensure all documentation complies with applicable FDA , SQF, and other regulatory standards + Assist with identifying and ... responsible for ensuring that all company documentation complies with regulatory requirements, food safety standards, and internal quality control...resolving issues related to compliance documents, in collaboration with QA management + Maintain… more
- Hologic (San Diego, CA)
- …in supporting quality activities related to Design Control efforts in accordance with FDA , ISO, and other IVD regulations. You will also support the company's ... quality system activities and design comply with the FDA 's Quality System Regulations (QSRs), ISO 13485, and applicable...team member on New Product Development projects to ensure compliance with design controls, as well as identify and… more
- Abbott (Sylmar, CA)
- …non-product software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures. As a global leader ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …leaders, operating with independence but under oversight from senior quality and regulatory compliance leaders. **Key Responsibilities** + This leader will ... planning and execution of Sustaining Engineering activities to keep products in compliance with applicable standards and improve customer experience. This role also… more
- Fujifilm (Sacramento, CA)
- …+ Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations ... in the development and structuring of new business ventures. + Keep abreast of legislative and regulatory changes that may affect HLUS and its subsidiary companies.… more