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- ...technology deployment Knowledge Knowledge of GAMP software development lifecycle ANSI/ISA-S88 and S95 industry standards and 21 CFR Part 11 Strong network architecture or engineering proficiencies including TCP/IP Routing Switching Network IDS/IPS Active Directory...SuggestedFull timeLocal areaFlexible hours
- ...First Aid Response Instructor A minimum of 2 years experience Full clean drivers licence essential Qualifications Desirable CFR-A Instructor Emergency First Response Instructor Personal Attributes Strong oral and written communication skills Attention...SuggestedPermanent employmentFull time
- ...manufacturing plant. A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11 21 CFR Part 11 is required. Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S...SuggestedPermanent employment
- ...Role: ~ Degree in science or engineering. ~3–5 years’ experience in medical devices. ~ Strong knowledge of ISO 13485 and FDA 21 CFR 820. ~ Strong understanding of MDR and FDA submissions. ~ Auditing experience (internal/external) is a plus. ~ Validation experience...SuggestedPermanent employment
- ...management Education / Experience Requirements Experienced professional with a good working knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820 & the principles of GMP. Degree in an engineering/quality or related discipline Certified QE desirable Technical...SuggestedHybrid work
Teleflex
Limerick1 day ago - ...responsible for assisting in administration of the quality management system at a site to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Quality Technician supports...Suggested
STERIS Canada Corporation
Westport, Co. Mayo3 days ago - ...cross-functional disciplines, both within and outside of the function and organization. Good working knowledge of ISA95 and ISA88, CFR Part 11, and EU Annex 11. Excellent communication skills, with the ability to formulate thoughts clearly and concisely to provide clarity...SuggestedContract work
Cpl Healthcare
Leinster2 days ago - ...contact Mark: ****@*****.*** or (***) ***-**** Key Responsibilities Ensure compliance with applicable regulations (ISO 13485, FDA 21 CFR Part 820, MDR, etc.) and company quality management systems. Provide quality engineering support for new product development,...Suggested
CREGG
Cork2 days ago - ...compiling analytical and/or manufacturing control sections of regulatory submissions is desirable A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage. Highly driven and motivated person who can work as part of a flexible,...SuggestedFlexible hours
Life Science Recruitment
Dublin18 hours ago - ...Regulatory & Quality Standards ~ Ensure quality systems are implemented and executed in compliance with: ~ ICH Q7 ~ EudraLex ~21 CFR requirements ~ Site Quality standards ~ Support data integrity initiatives, including compliance with GMP data integrity...Suggested
Westbourne IT Global Services
Dublin4 days ago - ...batch systems). Familiarity with GxP , GAMP 5 , Data Integrity concepts, and regulatory expectations for computerized systems (21 CFR Part 11, Annex 11) is a strong plus. Strong documentation skills and attention to detail. Ability to learn quickly in a regulated...SuggestedFull time
- ...operational readiness across interfaces Participate in validation activities (IQ/OQ/PQ) and ensure compliance with GxP GAMP and 21 CFR Part 11 standards. Maintain audit trails logbooks and documentation for regulatory inspections. Participate in system upgrades patches...SuggestedFull timeFor contractorsLocal areaShift work
- ...accordance with fair chance laws. U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from...SuggestedLong term contractFull timeLocal areaRemote workFlexible hours
- ...and industrial communication protocols Strong understanding of regulated industry documentation and validation standards (GAMP, 21 CFR Part 11, etc.). Proficient in generating technical documentation for both internal and customer-facing use. Comfortable working in...SuggestedPermanent employmentFull timeImmediate start
- ...Engineering or related technical field. ~ Hands-on experience with risk management (EN ISO 14971). ~ Strong knowledge of FDA QSR (21 CFR 820), EU MDD, and relevant standards. ~ Prior experience with US FDA submissions is a plus. For a confidential discussion and...SuggestedPermanent employment
€80k - €90k per annum
...related technical field. * 6 years QA, Quality System or regulatory experience in the medical industry. * Strong knowledge of FDA 21 CFR Part 820, ISO 13485:2016, EU MDR and international regulations. * Excellent communication, leadership and problem-solving skills....Permanent employment- ...Bachelor's degree in Computer Science, Engineering, or a related field. Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Experience in computer system validation within a regulated industry, preferably pharmaceuticals or...Daily paidContract work
- ...Bachelor's degree in Computer Science, Engineering, or a related field. ~ Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. ~5+ Years experience in computer system validation within a regulated industry, preferably pharmaceuticals...Contract work
- ...Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, ISO 14971 and Japanese Ministerial Ordinance # 169. Maintenance and continuous improvement of the quality management...Temporary workHybrid work
Life Science Recruitment
Galway1 day ago £ 56.11 - 64.74 per hour
...experience with microcontrollers and embedded systems, and knowledge of medical device compliance standards (ISO 13485, IEC 60601, FDA 21 CFR Part 11), this is your opportunity to make a significant impact. Key Responsibilities: Lead integration of embedded software and...Contract workHybrid workWork at officeLimerick12 days ago- ...documentation for laboratory instruments and equipment. Lead validation activities ensuring compliance with GMP, GAMP5, Annex 11, 21 CFR Part 11 and internal quality procedures. Develop, review, and execute validation protocols , test scripts, risk assessments, and...
Westbourne IT Global Services
Dublin2 days ago - ...documentation skills and attention to detail. ~ Experience with process plant commissioning. ~ Good working knowledge of ISA88, ISA95, CFR (Code of Federal Regulation) Part 11, EU (European Union) Annex 11. ~ Strong team player with the ability to develop relationships...
Process Automation – Controls.Instruments.Validations, Inc.
Munster4 days ago - ...to resolve manufacturing or quality issues. Ensure all operations comply with relevant QMS requirements , ISO 13485 , and FDA 21 CFR Part 820 regulations. Collaborate with internal and external partners (including suppliers and contract manufacturers) to ensure...Permanent employmentContract work
Wallace Myers International
Galway4 days ago - ...Knowledge of electrical control systems and Knowledge of automation lifecycle, validation, and data integrity (GAMP 5, Annex 11, FDA 21 CFR Part 11). Familiarity with aseptic processing and cleanroom Strong problem-solving, analytical, and communication #J-18808-...
Tandem Project Management Ltd.
Munster12 hours agonew - .... Your new role Ensure that all work on Lab IT and Benchtop Analytical equipment is carried out in a compliant manner, meets 21 CFR Part 11, EU Annexe 11, cGLP/GMP’s, and Corporate & local compliance requirements. Support the introduction of new instrument systems...Contract workLocal area
- ...all GxP relevant computerised systems are validated in accordance with applicable regulatory requirements (e.g. EU GMP Annex 11 FDA 21 CFR Part 11) and that data integrity principles are embedded throughout the lifecycle of these systems. ESSENTIAL DUTIES AND RESPONSIBILITIES...Full timeLocal areaWorldwide
- ...manufacturing plant. A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11 21 CFR Part 11 is required. Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance...Permanent employmentContract workWorldwide
- ...Key Responsibilities: Develop, implement, and maintain design quality assurance processes in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations and standards. Own new product introductions (NPI's) from beginning to end across a variety...Permanent employmentFull timeWorldwideWicklow Town, Co. Wicklowa month ago
- ...laboratory systems in compliance with FDA, EMA, and global regulatory expectations. Ensure adherence to GxP regulations, including 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles (ALCOA+). Develop, review, and approve CSV documentation including...Full time
- ...regulatory requirements. Regulatory Compliance & Influence: Implement regulatory expectations, maintain compliance with EU GMP Annex 1, 21 CFR, USP, EP, JP, and ICH guidelines, and stay current with emerging global regulations, audit trends and best practices. Training &...Worldwide
BIOMARIN
Cork1 day ago
