- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …various administrative tasks. 9. Strict adherence to procedures and practices according to FDA regulations. 10. Strong emphasis on documentation according to FDA ... Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. Administrative and high volume data entry processing… more
- Imperative Care (Campbell, CA)
- …team and ensure compliance with domestic and international regulatory standards (eg, FDA , CE marking, etc.). + Build and sustain relationships with cross-functional ... + Participate in audits by external bodies (Notified Body, FDA , etc.) and internal audits to maintain regulatory compliance....of education and work experience. + Expert knowledge of FDA regulations, EU regulations, and ISO standards. + Superior… more
- Abbott (Alameda, 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
- Bristol Myers Squibb (San Diego, CA)
- …clinical trial data and generating outputs to support DSUR/IBs, publications, FDA meeting briefing documents, and other internal ad-hoc requests + Collaborate ... statistical reporting. + In-depth knowledge of CDISC standards for SDTM, ADaM and FDA electronic data submission requirements. + Advanced Knowledge with FDA and… more
- J&J Family of Companies (Irvine, CA)
- …Define and execute the product security strategy aligned with business priorities, FDA /MDR/524B expectations, and QMS requirements. + Lead and grow a global product ... training, and pre-sale/post-installation engagements. + Represent product security in FDA and international regulatory inspections, reinforcing trust in our devices.… more
- UCLA Health (Los Angeles, CA)
- …study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). ... manage the preparation of clinical trials budgets. + Expert level experience with FDA processes and procedures. + Demonstrated ability to serve as a subject matter… more
- Kelly Services (Petaluma, CA)
- …to market. The company combines device and drug expertise, operates under strict FDA regulations, and is scaling up for upcoming product launches. Team members ... provide feedback to product teams. + Ensure trial data aligns with FDA requirements and supports regulatory filings. **Qualifications** + Bachelor's degree in… more
- Kelly Services (Petaluma, CA)
- …**What You'll Do** + Partner with engineering and quality teams to ensure FDA compliance on validations, CAPAs, and process changes. + Prepare and support ... FDA submissions, including Class I device registrations, Class II...pharmaceuticals, or combination products. + Strong working knowledge of FDA regulations, GMP, and 510(k) pathways. + Excellent documentation… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …with managerial oversight, as appropriate. + Serve as a liaison to the FDA 's Advertising and Promotional Labeling Branch for respective product(s) and will help ... ensure materials are submitted to FDA in a timely manner. + Ability to understand...advanced degree is also desirable. + Experience working with FDA 's Office of Prescription Drug Promotion or Advertising and… more
- Stanford University (Stanford, CA)
- …investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed. + ... executing randomized controlled trial treatment studies. + Experience with FDA regulatory procedures and reporting. + Demonstrated experience with regulatory… more