| Job alert | Jobs 1 - 10 of 195 |
Regulatory Affairs Specialist
Adecco Permanent Recruitment
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San Diego, CA
... • Interfaces with the FDA concerning issuing Certificates to Foreign Government for The company Corporation and its subsidiaries as needed. • Maintains Quality Assurance and Quality Management Certificates (ISO and CE) for The company and its ... - Apr 21
Associate Product Manager, Digital Solutions
Werfenlife SA.
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San Diego, CA, 92154
... Comply with applicable standard operating procedures (SOPs), ISO, FDA, and other applicable Quality System regulations as well as with applicable Environmental Health & Safety, Human Resources, and all other regulatory and administrative policies. ... - May 07
Clinical Research Coordinator I, SLASH
CEDARS-SINAI
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San Diego, CA, 92101
... Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Primary Duties and Responsibilities Independent study coordination including screening of potential ... - May 07
Sr. Dir/Director of Regulatory CMC
BioPhase
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San Diego, CA
... Manage interactions and maintain excellent relationships with regulatory authorities Represent the company in front of FDA and EMA and or local regulatory authorities and be able to defend the company’s strategy Education and Experience: MS/PhD ... - Apr 28
Senior Manager Quality Engineering
Raise
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San Diego, CA
... of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc) · Demonstrated experience with ISO, GxP, FDA or other key regulatory bodies · Able to take a systems approach and to understand the interaction between components (i.e. ... - Apr 26
Senior Labeling Specialist
BioPhase
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San Diego, CA
... QSR’s, ISO 13485, CMDR, IVDD Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies. Has awareness of device defects that may occur in their area of ... - May 06
Process and Equipment Validations Engineer
Nucleus Biologics
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San Diego, CA
... REQUIREMENTS: EDUCATION: · BS in engineering or other technical field · 3-5+ years of experience in a GMP or ISO 9001/13485 environment KNOWLEDGE AND EXPERIENCE: · Working knowledge of GMP, ISO, and FDA rules and regulatory requirements. · Proven ... - Apr 19
Regulatory Affairs Specialist
Cypress HCM
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San Diego, CA
... Prepare regulatory submissions for FDA A2F. Assist on the Registration/Application of Class II & III Medical Devices Licenses in Health Canada. Research FDA, CMDR, MDR, IVDR and UK MDR2002 guidance documents for regulatory requirements. Review ... - Apr 17
Clinical Research Coordinator I - Obstetrics & Gynecology - Accortt
CEDARS-SINAI
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San Diego, CA, 92101
... Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). Primary duties and responsibilities: Independent study coordination including screening of potential ... - May 07
Sr. Biostatistician-REMOTE
SimulStat
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San Diego, CA, 92122
... Responds to questions from the FDA and other regulatory authorities on statistical issues. Attend regulatory meetings to support and defend clinical programs. Collaborate with clinical scientists, thought leaders, and medical writers, both ... - May 02