- Abbott (Alameda, CA)
- …+ Knowledge of data collection best practices for clinical trials familiarity with regulatory frameworks (eg, FDA , EMA, ICH-GCP). + Knowledge of global clinical ... for maintaining comprehensive research documentation for audits, inspections and regulatory submissions. Develop and/or conduct the continuous review the IQRMP… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …externally at conferences and scientific meetings. + Represent BDB externally with regulatory agencies, notified bodies, FDA , etc. + Ensure customer perspectives ... aspects-from concept through to commercialization-with a sharp focus on scientific rigor and regulatory compliance. This new role is ideal for someone who thrives in… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …engineering processes and/or systems + Expert knowledge of domestic and international regulatory requirements (eg, FDA , GMPs, and ISO/EN standards) + Expert ... knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing + Demonstrated ability to direct teams and provide coaching and feedback,… more
- Kelly Services (Lodi, CA)
- …lifecycle. + **Technical Skills:** + Familiarity with ISO standards and regulatory requirements (CE/ FDA /QSR, GDP). + Strong documentation and record-keeping ... skills. + **Qualifications & Skills:** + Education: High school diploma or equivalent required. + Experience: Minimum of 2 years in a manufacturing or regulated environment. + Must be comfortable working in an environment where you have to wear PPE at all… more
- Kelly Services (Irvine, CA)
- …effectively, both in writing and verball_ + _Familiarity with quality and regulatory systems including FDA 's Quality System Regulation, ISO13485_ _Applicants ... must be legally permitted to work in the United States immediately and without employer sponsorship._ As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers… more
- Chipotle Mexican Grill (Newport Beach, CA)
- …and professional groups such as CPS, LGMA, etc. + Accustomed to working with FDA , USDA, State and Local Regulatory Agencies. + Bilingual in English/Spanish ... preferred + Proven ability to develop and implement programs that improve food safety and quality monitoring. + Ability to analyze data, perform statistical analysis, proficient in MS Office. + Self-starter: has the motivation, discipline, and mindset to get… more
- Sharp HealthCare (San Diego, CA)
- …follow through, and prevention.Assists in maintaining CAP, JCAHO, CA state, AABB, FDA , and other accreditation and regulatory agency standards and ... regulations.Demonstrates emotional intelligence, critical thinking, and logical decision-making, especially under critical and stressful situations, to reach acceptable resolutions. + Test processes by evaluating quality control systems, data and… more
- Novo Nordisk (San Diego, CA)
- …within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...strong knowledge of clinical development/operations and working knowledge of FDA requirements required A strong knowledge of health economics… more
- Astrix Technology (Irvine, CA)
- …System policies and procedures and applicable external requirements and standards, including FDA , ISO 13485, and other worldwide regulatory agencies pertaining ... Science + Years' Experience: 0-1 years + Familiarity with regulatory reporting requirements for medical devices (eg MDRs, Vigilance...device complaint files and quality records + Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803… more
- Abbott (Alameda, CA)
- …with all levels of the organization. + Ensure all automation processes comply with FDA , ISO 13485, and other relevant regulatory standards. + Maintain detailed ... streamline product return workflows, and ensure compliance with global regulatory standards. By aligning business needs with technical capabilities, this… more