- Abbott (Santa Clara, CA)
- …regulations and experience such as from the Food and Drug Administration ( FDA ) Center for Devices and Radiological Health (CDRH). This Senior Manager Regulatory ... device business units for new products or changing existing products especially with FDA + Supports and provide critical review of key documents necessary for… more
- BeOne Medicines (San Mateo, CA)
- …The individual will have extensive experience with the United States FDA , oncology division, leading key interactions including supporting advisory committee (ODAC) ... the job:** + Uses extensive knowledge of the US FDA regulatory environment and the ability to apply knowledge...and risk assessments, critical issue management and advice on FDA interactions. + Oversees the preparation of NA regulatory… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …frameworks, Agile SDLC, experience with cross functional team transactions, and various FDA SW related guidance's and industry best practices. The role involves ... and execute comprehensive regulatory strategies for SaMD products in alignment with FDA regulations and guidance documents. + Provide regulatory input during the… more
- Abbott (San Diego, CA)
- …development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They play a crucial role in software design, coding, and ... activities under guidance and mentoring junior engineers. Adherence to FDA -compliant Design Control procedures and proficiency in software implementation are… more
- Gilead Sciences, Inc. (Foster City, CA)
- …expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP BRH ... operations, ensuring alignment with industry regulations such as GxP, FDA , and 21 CFR Part 11. Design scalable, efficient,...comply with relevant Life Sciences industry regulations, including GxP, FDA , EMA, and other regulatory bodies. + Lead the… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …CGTO & SAP SD, MM & PP modules, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP CGTO ... operations, ensuring alignment with industry regulations such as GxP, FDA , and 21 CFR Part 11. Design scalable, efficient,...comply with relevant Life Sciences industry regulations, including GxP, FDA , EMA, and other regulatory bodies. + Lead the… more
- Robert Half Finance & Accounting (Oakland, CA)
- …opportunities, and driving savings while maintaining the product quality required for FDA regulatory compliance. This is a hands-on role in an organization where ... + Monitor the cost impact of design or process changes associated with FDA approval cycles or regulatory requirements. Continuous Improvement: + Evaluate the cost… more
- Abbott (San Diego, CA)
- …risk assessments and contribute to risk mitigation strategies aligned with FDA and international cybersecurity guidance. + Implementation of security risk controls ... ComplieswithU.S. FoodandDrugAdministration ( FDA )regulations,otherregulatoryrequirements, Companypolicies,operatingprocedures,processes,andtaskassignments.… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …plasma derived pharmaceuticals. + Strict adherence to procedures and practices according to FDA regulations. + Strong emphasis on documentation according to FDA ... + Minimum of 3 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. + Demonstrated leadership skills with the ability to… more
- Kelly Services (Sunnyvale, CA)
- …development, especially, design control and risk management activities in accordance with FDA and ISO regulations. This position is part of the Product Lifecyle ... ensure continued compliance with internal procedures and applicable US FDA , EU IVDR, and other global standards. + Provide...pharmaceutical industry with applicable knowledge of cGMP, ISO, and FDA regulations (ISO 13485, ISO 14971, FDA … more