- Oura (San Francisco, CA)
- …influence cross-functional teams. The successful candidate will possess expertise in FDA frameworks governing digital health products, including wearable devices and ... regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance: + Serve as the...Compliance: + Serve as the primary legal advisor on FDA , EU MDR, and other global health compliance requirements,… 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 (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
- Actalent (Vista, CA)
- …the development and maintenance of the Quality Management System, obtaining FDA and ISO certifications, and product submission and registration. Responsibilities + ... and submission of high-quality supplements, annual reports, control documents, etc. to FDA authorities. + File Vigilance Reports or Medical Device Reports to… more
- Hologic (San Diego, CA)
- …representative ensuring that our products are meeting industry standards and FDA requirements throughout the product lifecycle, including post-market. This is a ... Regulatory teams to provide security input for audits and FDA submissions. + Maintain current knowledge of FDA... FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards,… 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
- Kelly Services (Petaluma, CA)
- …logistics, and facilities. The ideal candidate brings extensive experience within FDA -regulated environments and has a proven ability to drive operational ... time improvement, and capacity planning. + Ensure compliance with FDA regulations (21 CFR Part 820) and other applicable...medical device or pharmaceutical industry. + Strong knowledge of FDA regulations, including 21 CFR Part 820. + Proven… more
- Abbott (Sylmar, CA)
- …Follow approved Design Control procedures for software development in accordance with FDA guidelines. + Contributes to and supports root-cause analysis of failures. ... projects. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… 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
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