- Abbott (Alameda, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... healthcare , with leading businesses and products in diagnostics, medical...identification/stochastic modeling and algorithm development for sensor systems through FDA clearance or approval. **Preferred** + A master's degree… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …Patient Monitoring** , a leading MedTech company dedicated to revolutionizing healthcare through cutting-edge technology and advanced algorithms. We are committed to ... for developing innovative solutions that make a difference in healthcare . As a Senior Systems Engineer, you will play...development from concept to market + Strong knowledge of regulatory requirements and quality standards in the medical device… more
- Gilead Sciences, Inc. (Foster City, CA)
- …that align with the Medical Affairs goals while ensuring compliance with ACCME, FDA , OIG, and other relevant guidelines (as well as Gilead policies and ... federal/state/local statutes and regulations). Staying abreast of industry trends and regulatory changes in the medical education is crucial to inform… more
- Philips (San Diego, CA)
- …integration and V&V, ensuring compliance with medical device standards and global regulatory requirements. + You will develop and execute engineering strategies and ... medical device environment: demonstrating practical knowledge and experience with global regulatory requirements and industry standards (eg, IEC 60601, IEC 62304,… more
- Cedars-Sinai (Beverly Hills, CA)
- …compliance with local, state and federal laws; accreditation, professional and regulatory agency standards and licensure requirements. Maintains staff and program ... research staff and ensure compliance with federal and local regulations, including FDA and IRB requirements. + Develop and implement strategies to increase patient… more
- University of Southern California (San Diego, CA)
- …educated and trained on current industry standards. Experience + Bachelor's degree in science/ healthcare related field required. + A minimum of 3 years experience in ... required + Thorough understanding of records management requirements in FDA regulated trials + Ability to build and maintain...on TMF Reference Model updates, industry best practices and regulatory requirements + Other duties as assigned USC will… more
- Sutter Health (Sunnyvale, CA)
- …adequate stock levels, checking accuracy of pricing, and completing required regulatory documentation. Adheres to all standards, procedures, cleaning protocols, and ... Services (DHS), Drug Enforcement Administration (DEA), Food and Drug Administration ( FDA ) and the United States Pharmacopeia (USP) organization. Possess solid… more
- Stryker (Irvine, CA)
- …process-related issues. + Document processes, validations, and risk assessments in compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 25539 (vascular implants). ... (Minitab, JMP). + Familiarity with risk management (DFMEA, PFMEA) and regulatory expectations for Class II/III interventional devices. + Hands-on experience with… more
- Abbott (San Diego, CA)
- …Therapies product line. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... Abbott is a global healthcare leader that helps people live more fully...Our portfolio of life-changing technologies spans the spectrum of healthcare , with leading businesses and products in diagnostics, medical… more
- Danaher Corporation (West Sacramento, CA)
- …we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always ... and will be on-site role. At Beckman Coulter, our vision is to relentlessly reimagine healthcare , one diagnosis at a time. You will be a part of the Microbiology R&D… more