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2nd shift Factory Production Supervisor at Yakult USA

TriCom Quest  –  Fountain Valley, CA
... to all hourly factory employees, as well as reporting on issues to the factory production manager: Supervise 30+ employees to ensure security, safety, specs, quality assurance of products, sanitation, HACCP, and FDA regulations are followed. ... - Jun 18

Sr. Quality Assurance Engineer

Prismatik  –  Irvine, CA
Description Position at Prismatik Essential Functions: Leads the ongoing implementation of Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and ... - Jun 20

Regulatory Affairs Manager

eVent Medical Ltd  –  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 20

Clinical Research Nurse

City of Hope  –  Irvine, CA
... Ensure the consent process is performed in compliance with institutional, FDA, IRB, clinical trial sponsor and other applicable regulations. - Jun 18

Director, Regulatory Compliance

RXSIGHT INC  –  Aliso Viejo, CA
... •Establish and maintain system for tracking regulatory approvals internationally including device version approvals •Maintain current knowledge of FDA and international regulations (CE, EUMDR, ISO, etc.), guidance and standards applicable to company ... - Jun 08

Regulatory Affairs Specialist

Brett Fisher Group  –  Irvine, CA, 92602
... Main Tasks/Accountabilities Lead regulatory strategy and submissions to the FDA and state regulatory authorities for new product approvals and supporting activities for existing ones. Provide regulatory guidance to the assigned product development ... - Jun 20

Senior Embedded Software Engineer

Willow Laboratories  –  Irvine, CA
... Low Energy · Familiarity with Qt and Linux systems · Knowledge of QMS, FDA design controls and GMP regulation · Familiarity with electronic hardware design · Experience working in both large structured and small entrepreneurial organizations - May 31

Per Diem Nurse- Blood Donor Center, Irvine- Variable Shift

University of California, Irvine  –  Orange, CA
... in person, with a wide range of people in an effective professional manner Preferred Qualifications: Understanding of FDA, DHS, AABB, CAP, Title 22, Joint Commission, and CDC guidelines Licenses and Certifications: BLS (Required) Conditions of ... - Jun 20

Director, Regulatory Affairs

RXSIGHT INC  –  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  –  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
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