Fda Jobs in Galway
Director of Regulatory Affairs
Life Science Recruitment Ltd - Galway
, and market expansion activities. Manage all regulatory submissions (CE marking, FDA 510(k)/PMA, and other global submissions) and ensure alignment with commercial and operational timelines. Serve 100000.0
from: irishjobs.ie - 15 days ago
Quality Systems Engineer
Sigmar Recruitment - Galway
into compliance with the current US FDA QMSR. Working in the QA Dept, and directed by the QA/RA Manager, the successful candidate will drive day to day responsibility for the change and development of current 55000.0
from: irishjobs.ie - 20 days ago
Senior Manufacturing Engineer
Sigmar Recruitment - Galway
, and quality issues. Lead validation efforts develop protocols, execute tests, analyze data. Support CAPAs, audits, and compliance with ISO 13485 and FDA standards. Develop SOPs, work instructions, and training 75000.0
from: irishjobs.ie - 19 days ago
Clinical Affairs Specialist
Wallace Myers International - Galway
and regulatory authorities such as the FDA and Competent Authorities. Liaise with external vendors such as CROs, core labs, and biostatisticians. Liaise with study coordinators and investigational site personnel 60000.0
from: irishjobs.ie - 15 days ago
Quality Systems Technician
Smart Reactors Service Limited - Galway
13485/ 21 CRF Part 820 Experience 2+ years industry experience working in a regulated medical device/ manufacturing area. Good knowledge of FDA 21CFR820 and international regulatory requirements
from: irishjobs.ie - 15 days ago
Quality Director
Life Science Recruitment Ltd - Galway
Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR 820, MDR, and other applicable standards and regulations. Partner closely with Operations, R&D, Regulatory Affairs 100000.0
from: irishjobs.ie - 15 days ago
Quality Engineer II
Sigmar Recruitment - Galway
experience in medical device manufacturing. Familiarity with FDA and EU regulatory requirements, including QSR and ISO standards. Demonstrated ability to manage priorities, solve complex problems, and lead 70000.0
from: irishjobs.ie - 15 days ago
Training Program Manager
CareerWise Recruitment - Galway
role, with experience in the life sciences or laboratory services industry. * Strong understanding of lab procedures, equipment, and industry regulations. Familiarity with ISO, OSHA, and FDA standards 70000.0
from: irishjobs.ie - 27 days ago
Director of Engineering
CareerWise Recruitment - Galway
with Oversee process development, technology transfer, and automation initiatives to enhance manufacturing efficiency Ensure compliance with HPRA, FDA, GMP, cGMP, ISO, and other global regulatory standards 100000.0
from: irishjobs.ie - 26 days ago
Quality Engineer II- Medical Device Start-up
Wallace Myers International - Galway
engineering, life science or related field. 3-5 years experience at a quality assurance role in the medical device sector essential, preferably in a FDA/MDR regulated environment. Quality certification and lead 60000.0
from: irishjobs.ie - 29 days ago
