- Genentech (South San Francisco, CA)
- …and partnerships; + Advising regulatory , medical affairs, and other clients on FDA regulatory submissions, label negotiations and privacy and data use; + ... product sales and marketing, commercial strategic and operational functions, regulatory , market access (patient access, pricing, contracting and distribution), US… more
- Hologic (San Diego, CA)
- …input for audits and FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance and standards, such as ISO, ... regulated environment is required. + Thorough familiarity with FDA and other regulatory body Cybersecurity Guidelines and cybersecurity standards such as NIST,… more
- Parexel (Sacramento, CA)
- …related industry experience. * Direct experience in advertising and promotional regulatory review. * Familiarity with FDA regulations governing promotional ... timelines. * Excellent communication skills, with the ability to explain regulatory concepts, including FDA regulations/guidances, clearly to cross-functional… more
- Oracle (Sacramento, CA)
- …all device software, ensuring vulnerability management and cybersecurity compliance with FDA and global regulatory expectations. + Apply the organization's ... standards such as IEC 62304, IEC 82304, and relevant FDA guidance. + Proven ability to apply regulatory... FDA guidance. + Proven ability to apply regulatory requirements to software design, documentation, and development practices.… more
- Stanford University (Stanford, CA)
- …including project management in a dynamic research setting. + Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, ... Regulatory Specialist (Hybrid Opportunity) **School of Medicine, Stanford,...prepare documents for submission as required by the IRB, FDA , OSP and APB requirements, including annual reports, and… more
- AbbVie (Irvine, CA)
- …with a demonstrated ability to communicate clearly and professionally. + Knowledge of FDA and regulatory statutes as applied to Allergan Aesthetics products, ... educational opportunities and deficiencies + Management of our Medical, Legal, Regulatory , and Compliance review systems and processes, ensuring timely and quality… more
- Meta (Burlingame, CA)
- …Devices, Regulatory Affairs Specialist Responsibilities: 1. Interact directly with FDA and/or indirectly with international regulatory agencies on most ... **Summary:** We're seeking a regulatory affairs specialist to join our medical devices...vigilance reporting, product recalls, etc., as needed 3. Prepare FDA , European and Canada submissions for product changes as… more
- Kelly Services (Irvine, CA)
- …and semi-solid dosage forms. + Knowledge of **cGMP** , **USP** , and ** FDA ** regulatory requirements. + Experience preparing CMC documentation for ANDA filings ... analytical methods for drug products in accordance with USP and regulatory guidelines. + Author and execute method validation or verification protocols… more
- Stanford University (Stanford, CA)
- …to precision medicine in mental health and neuroimaging trials + Experience with FDA regulatory procedures and reporting + Demonstrated capacity to solve ... audit study forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed. +… more
- Abbott (San Diego, CA)
- …new capabilities. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... development, and validation of software for embedded systems, ensuring compliance with FDA requirements. They play a crucial role in software design, coding, and… more