| Job alert | Jobs 61 - 70 of 379 |
Director, Regulatory Affairs
RXSIGHT INC
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Aliso Viejo, CA
... Responsibilities include: • Preparing international regulatory submissions and FDA submissions which may include Technical Documents, Technical Files, Device License Applications and Amendments, and PMAs • Identifying and gathering data needed to ... - Jun 08
Associate Director, Regulatory Affairs
AbbVie
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Irvine, CA, 92650
... Manages interface with Health Authority for US FDA for key projects/issues, including direct collaboration with review division personnel. Also serves as primary liaison and interfaces with FDA for meetings, teleconferences and coordinates ... - Jun 20
Clinical Research Coordinator
University of California, Irvine
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Orange, CA
... Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors. ... - Jun 24
Senior Field Service Engineer - HYBRID (Newport Beach, CA)
RefleXion Medical
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Newport Beach, CA
... Designated an FDA Breakthrough Device for lung tumors, RefleXion's SCINTIX® biology-guided radiotherapy aims to overcome long-standing barriers preventing definitive radiotherapy for metastatic disease. FDA-cleared SCINTIX therapy automates ... - Jun 14
Clinical Research Nurse Coordinator II, Oncology
CHOC - Children's Health Orange County
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Orange, CA
... Nurse Coordinator II is responsible for providing coordinator assistance for sponsored clinical studies within the Center for Clinical Research in accordance with Institutional policy, Good Clinical Practice and ICH guidelines as adopted by the FDA. ... - Jun 17
Business System Analyst
Interactive Resources - iR
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Irvine, CA
... Experience with FDA and international medical devices regulatory processes. Knowledge of regulatory requirements impacting computer system validations. Collaborate with Project Managers / Analysts in resolving conflicts, analyzing critical ... - Jun 18
Supply Chain Associate
BioPhase Solutions
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Santa Ana, CA, 92707
... Knowledge of the technical, GMP, and FDA requirements for the manufacturing of aseptic parenteral products. Knowledge of job related techniques and principles with an ability to work on routine assignments independently, requiring instructions and ... - Jun 21
Clinical Research Regulatory Coordinator
The Oncology Institute of Hope and Innovation
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Cerritos, CA
... Demonstrated knowledge and understanding of human research policies, regulations, procedures, and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines. Demonstrated knowledge of FDA and Sponsor regulatory requirements. Knowledgeable of ... - Jun 25
Regulatory Affairs Manager
eVent Medical, Ltd
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Lake Forest, CA, 92630
... · Develop processes to ensure quality system compliance with the FDA Quality System Regulation (21 CFR Part 820, Part 803, Part 11). · Provide regulatory information and assistance for the Design, service and other technical functions in the company ... - Jun 18
Senior Systems (Validation) Engineer
DIALITY INC
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Irvine, CA, 92618
... Ensure all human factors engineering activities comply with FDA Human Factors Engineering Guidance. Conduct formative and summative evaluations as specified by FDA human factors guidelines to identify and mitigate potential use errors. Create ... - Jun 19