- Astrix Technology (Pomona, CA)
- …and evaluating personal care products to ensure they meet established quality standards, regulatory compliance , and customer expectations._ **Contract length:** ... personal care products comply with industry regulations and standards, such as FDA guidelines, and work towards continuous improvement in meeting these requirements.… more
- Abbott (Alameda, CA)
- …clinical research or related field. + Education and work experience in research compliance , or quality , project management, or life sciences or clinical ... to lead and manage the development, documentation, and execution of risk-based quality management process, as described in the risk assessment, data management plan,… more
- Abbott (Temecula, CA)
- …to all sites and customers. Must ensure that all molds are run in compliance with all quality standards and procedures. **EDUCATION AND EXPERIENCE YOU'LL ... help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with...Knowledge of plastics processes, resins, tooling required. Knowledge of FDA QSR's and ISO requirements preferred. **WHAT WE OFFER… more
- Cedars-Sinai (Beverly Hills, CA)
- …effective services. Participates in Research and IRB related activities to assure compliance with federal, state, FDA , and other regulations. Develops policies, ... Support **Business Entity** : Cedars-Sinai Medical Center **Job Category** : Compliance / Quality **Job Specialty** : Patient Safety **Overtime Status** : EXEMPT… more
- Globus Medical, Inc. (San Diego, CA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... designs + Carries out hardware integration tasks + Maintains compliance with standards typical of the medical industry +...for embedded system + Familiar with ISO 13485 and FDA 21 CFR part 820 design control processes +… more
- GRAIL (Menlo Park, CA)
- …ability to be flexible and creative yet ensuring the clinical trial is executed within compliance of regulations and of the highest quality , and to be able to ... training and management, provides ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, FDA... compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all… more
- Mentor Technical Group (Millbrae, CA)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …**Responsibilities:** + Lead and develop direct report associates to ensure regulatory compliance + Problem solve and escalate regulatory and compliance issues ... effort to comply with new and existing regulations (eg, FDA Medical Device Regulations, EU-MDR) + Support the monitoring,...experience including SaMD/SiMD is a plus + Regulatory and Quality Information Management systems such as SAP, RIM, or… more
- Sumitomo Pharma (Sacramento, CA)
- …(SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, ... cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of "Safety First"… more
- Sumitomo Pharma (Sacramento, CA)
- …Summary of Efficacy (ISE) strategy for NDA/BLA submissions, ensuring compliance with regulatory expectations. + Collaborate closely with cross-functional ... Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts to ensure accuracy in data...Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus… more