- Cedars-Sinai (Los Angeles, CA)
- …for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for ... study budget and patient research billing. Ensures compliance with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to the study and… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry; QA administration and planning experience required. + Minimum 3 ... + Lead Quality System auditor experience. + Experience managing regulatory audits and responding to regulatory authorities....and ISO14971 + Quality system auditing + Management of FDA and notified body audits. + Risk Management +… more
- Abbott (Alameda, CA)
- …the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. This is an individual contributor position which ... File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures. + Develops and maintains… more
- Cedars-Sinai (Los Angeles, CA)
- …all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board (IRB). Primary Duties and Responsibilities + ... concerns regarding data quality and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit… more
- AbbVie (Irvine, CA)
- …R&D organization in navigating enterprise-critical issues in an evolving legal and regulatory environment as we work to bring new, innovative products to patients. ... leaders within the R&D and corporate strategy organizations on legal and regulatory issues that impact pipeline development, government agency engagement and product… more
- Cedars-Sinai (Los Angeles, CA)
- …for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for ... billing. This role will comply with all federal, local, FDA , IRB, and HIPAA guidelines and regulations pertaining to...contact for long term follow-up patients only. Assists with regulatory submissions to the Institutional Review Board (IRB) and… more
- Actalent (Irvine, CA)
- …a highly experienced Level III Quality Systems Engineer to join our Quality and Regulatory team. This role is critical in ensuring the integrity and compliance of ... documentation. + Evaluate claims for accuracy, scientific validity, and compliance with regulatory standards. + Assess claims made for different user populations to… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity. The leader will be responsible ... and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory Authority Engagement:** Act as the primary… more
- Cordis (Irvine, CA)
- …at every stage of the manufacturing process, ensuring compliance with regulatory standards and internal quality requirements. + Process Improvement: Lead the ... mitigation to ensure the safety and efficacy of medical devices. + Regulatory Compliance: Stay up-to-date with regulatory requirements, standards, and guidelines… more
- Owens & Minor (Irvine, CA)
- …medical supplies onto delivery vehicle. + Complies with all applicable regulatory requirements including providing documents needed for the driver qualification file ... is performed on a timely basis according to DOT, FDA and Joint Commission. + Responds to emergency delivery...+ Must meet job-related requirements to comply with DOT, FDA and Joint Commissions regulations. **SKILLS, KNOWLEDGE AND ABILITIES**… more