- Gilead Sciences, Inc. (Foster City, CA)
- …+ BS/BA required along with 10+ years of related experience in the pharmaceutical, medical device , or biotech industry. + Prior leadership roles in Patient ... vendors, as well as internal departments such as Marketing, Analytics, Training, Compliance , Medical , Regulatory, and Legal + Liaise with leadership teams,… more
- Amentum (San Diego, CA)
- …8510.01 and ICD 503. The duties of this task include assessing network compliance against controls listed in NIST 800-53 and creating A&A packages. Performs ... assessment, compliance , and validation of IT systems to support the...* Perform network, cloud, information systems, hardware, software and device security authorization and assessments, as well as the… more
- CTG (Woodland, CA)
- …* Minimum 3 years' experience in Quality or Regulatory, preferably in medical device , pharmaceutical, or biotechnology industries * Strong knowledge and ... is responsible for new product setup, quality project management, and ensuring regulatory compliance for serum products. The position will ensure compliance with… more
- Abbott (Alameda, CA)
- …issues + Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies in the ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- NTT America, Inc. (Sacramento, CA)
- …where you can grow, belong and thrive. **KEY RESPONSIBILITIES** + Ensures work compliance within Federal, State, and local guidelines as well as requirements related ... + Reviews equipment submittals and shop drawings for overall compliance with the design intent. + Reviews final pre-functional...with working remotely and use of a personal mobile device , if applicable. NTT Global Data Centers Americas, Inc.… more
- Danaher Corporation (Sunnyvale, CA)
- …(IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) participating regulatory authorities ... implement improvements. This position will work with the Senior Manager Quality Systems Compliance . This position is part of the Quality department and will be… more
- Imperative Care (Campbell, CA)
- …Process Validation principles. + Ability to comprehend principles of engineering, physiology, and medical device use Employee Benefits include a stake in our ... objectives. + Lead the design assurance team and ensure compliance with domestic and international regulatory standards (eg, FDA,...Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820; ISO 13485 and… more
- Abbott (Sylmar, CA)
- …diverse and growing portfolio of digital health products, including software as a medical device (SaMD), connected devices, and digital health platforms. This ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Alameda Health System (Oakland, CA)
- …Reports all serious adverse events and protocol violations. Submits drug and/or device safety reports to the IRB. REGULATORY:Organizes research team and meets as ... serious adverse events to study sponsor and FDA, when appropriate. Ensures compliance with all federal and state laws regarding research and confidentiality. In… more
- Cedars-Sinai (Los Angeles, CA)
- …for the external sponsors. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report ... coordinate activities, training, and education for other Clinical Research Associates. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and… more