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Tynagh Quality Compliance Specialist Jobs + 30 km
No match yet? There are 5 more jobs that could match your search
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Senior Regulatory Affairs Specialist - PVH
Senior Regulatory Affairs Specialist - PVH
Medtronic Vascular Galway UC
Galway, Republic of Ireland
€ Not Disclosed
Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support. Recommends changes for labeling and internal documentation, reports for regulatory compliance. Support review of internal procedures to ensure continuous compliance with all regulatory requirements. Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support. Recommends changes for labeling and internal documentation, reports for regulatory compliance. Support review of internal procedures to ensure continuous compliance with all regulatory requirements. Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
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Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Life Science Recruitment Ltd
Galway, Republic of Ireland
€ Not Disclosed
Job title: Senior Regulatory Affairs Specialist Post market - Responsible for the implementation of PMS activities identified under Post Market Regulatory Reporting and change assessment as defined in relevant Quality System procedures and Work Instructions. - Provide support to other RA Specialists in achieving success for the team.
Job title: Senior Regulatory Affairs Specialist Post market - Responsible for the implementation of PMS activities identified under Post Market Regulatory Reporting and change assessment as defined in relevant Quality System procedures and Work Instructions. - Provide support to other RA Specialists in achieving success for the team.
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Senior Design Assurance Engineer- Med Device Startup
Senior Design Assurance Engineer- Med Device Startup
Wallace Myers International
Galway, Republic of Ireland
€60,000 - €75,000 per annum
Establish and maintain appropriate procedures to ensure compliance with regulatory requirements. * Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to product development, manufacture and subsequent commercialization. * Maintain accurate and up-to-date design history files (DHF) and other design-related documentation in compliance with regulatory requirements. * Minimum of 3-5 years of experience in design assurance or quality engineering within the medical device industry, preferably with neuro interventional devices. Quality Assurance Design Assurance Medical Devices Design Control Design reviews
Establish and maintain appropriate procedures to ensure compliance with regulatory requirements. * Demonstrate an ability to apply, recommend and/or create quality tools and apply them effectively to a variety of business situations related to product development, manufacture and subsequent commercialization. * Maintain accurate and up-to-date design history files (DHF) and other design-related documentation in compliance with regulatory requirements. * Minimum of 3-5 years of experience in design assurance or quality engineering within the medical device industry, preferably with neuro interventional devices. Quality Assurance Design Assurance Medical Devices Design Control Design reviews
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As Regulatory Affairs Specialist,you willIdentify products compliant or not with regulatory requirements in our current markets and liaise with non-compliant potential suppliers. * Lead strategic quality improvement projects and initiatives which enhance the long-term sustainability of the company * Lead Management Review process; report on the performance of the Quality System - regulatory specialist Organised
As Regulatory Affairs Specialist,you willIdentify products compliant or not with regulatory requirements in our current markets and liaise with non-compliant potential suppliers. * Lead strategic quality improvement projects and initiatives which enhance the long-term sustainability of the company * Lead Management Review process; report on the performance of the Quality System - regulatory specialist Organised
Ensures personal understanding of all quality policy/system items that are personally applicable and carries out duties in compliance with established business policies. * Follows all work/quality procedures to ensure quality system compliance and high-quality work. The Regulatory Affairs Specialist provides a support role to the IDEM Business Unit, their Manufacturing Site and key project activities. The Regulatory Affairs Specialist reports to the Manager of Regulatory Affairs. This includes supporting global certification activities and regulatory compliance activities, including manufacturing site registration, external regulatory agency audits and internal audits as needed. * Support all Company initiatives as id
Ensures personal understanding of all quality policy/system items that are personally applicable and carries out duties in compliance with established business policies. * Follows all work/quality procedures to ensure quality system compliance and high-quality work. The Regulatory Affairs Specialist provides a support role to the IDEM Business Unit, their Manufacturing Site and key project activities. The Regulatory Affairs Specialist reports to the Manager of Regulatory Affairs. This includes supporting global certification activities and regulatory compliance activities, including manufacturing site registration, external regulatory agency audits and internal audits as needed. * Support all Company initiatives as id
4 exact matches jobs are outside your preferred location
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Quality Compliance Specialist - Change Control
Quality Compliance Specialist - Change Control
Regeneron Ireland DAC
Limerick, County Limerick
€ Not Disclosed
We are currently looking to fill a Quality Compliance Specialist - Change Control position on the Quality Assurance Change Control Team. * Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory - Experience with Quality Management Systems heavily preferred - To be considered for this position you must have a Bachelor's in a scientific or engineering discipline or related field with 3+ years' experience in a combination of Quality, Production, Engineering, Regulatory (Chemistry, Manufacturing and Control) and/or Laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements.
We are currently looking to fill a Quality Compliance Specialist - Change Control position on the Quality Assurance Change Control Team. * Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP, FDA regulations and familiarity with ICH guidelines and global regulatory - Experience with Quality Management Systems heavily preferred - To be considered for this position you must have a Bachelor's in a scientific or engineering discipline or related field with 3+ years' experience in a combination of Quality, Production, Engineering, Regulatory (Chemistry, Manufacturing and Control) and/or Laboratory, with demonstrated accomplishments in effectively implementing cGMP requirements.
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Associate Manager Compliance (Sourcing)
Associate Manager Compliance (Sourcing)
Regeneron Ireland DAC
Limerick, County Limerick
€ Not Disclosed
The Associate Manager Compliance - Sourcing is responsible for overseeing a team of Strategic Sourcing & Procurement Compliance Specialists that support and maintain all cGMP compliance aspects of procurement operations. The major activities include but are not limited to the following: management and facilitation of the Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and evidence follow up, support of regulatory inspections, SOP writing and revision, change controls, and the management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. Other compliance tasks/functions as assigned. * Leading and developing some of the Global IOPS Strategic Sourcing & Procurement
The Associate Manager Compliance - Sourcing is responsible for overseeing a team of Strategic Sourcing & Procurement Compliance Specialists that support and maintain all cGMP compliance aspects of procurement operations. The major activities include but are not limited to the following: management and facilitation of the Approved Supplier List (ASL), deviation investigations, CAPAs, supplier audit closures and evidence follow up, support of regulatory inspections, SOP writing and revision, change controls, and the management of the development of a Supplier Corrective Action Report (SCAR) management process via the compliance function. Other compliance tasks/functions as assigned. * Leading and developing some of the Global IOPS Strategic Sourcing & Procurement
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The Ireland team is part of the International Compliance team of the Northern Trust Group and works closely with regional and global compliance partners. The continued growth and scale of our business in Ireland has created the need for a dedicated Head of Compliance (PCF-12) for our fund administration entity. The successful candidate will manage one direct report and work alongside the PCF-12 for the depositary entity as well as the Ireland compliance shared service team. This role reports to the International Chief Compliance Officer in the UK, the Board of Directors and is subject to the approval of the Central Bank of Ireland ("CBI"). * Maintain and embed a comprehensive compliance framework for NTIFASIL, leveraging (where practical) the Northern Trust Group
The Ireland team is part of the International Compliance team of the Northern Trust Group and works closely with regional and global compliance partners. The continued growth and scale of our business in Ireland has created the need for a dedicated Head of Compliance (PCF-12) for our fund administration entity. The successful candidate will manage one direct report and work alongside the PCF-12 for the depositary entity as well as the Ireland compliance shared service team. This role reports to the International Chief Compliance Officer in the UK, the Board of Directors and is subject to the approval of the Central Bank of Ireland ("CBI"). * Maintain and embed a comprehensive compliance framework for NTIFASIL, leveraging (where practical) the Northern Trust Group
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This job will suit a Senior Regulatory Compliance Specialist looking for the next step in their career or a Regulatory Compliance Manager looking for a new challenge. Provision of expertise, advice and project implementation and execution to ensure maintains compliance to relevant chemical and health & safety regulatory obligations. * 5+ years of experience in a regulatory compliance role - Regulatory Chemistry Compliance
This job will suit a Senior Regulatory Compliance Specialist looking for the next step in their career or a Regulatory Compliance Manager looking for a new challenge. Provision of expertise, advice and project implementation and execution to ensure maintains compliance to relevant chemical and health & safety regulatory obligations. * 5+ years of experience in a regulatory compliance role - Regulatory Chemistry Compliance