Average salary: €76,311 /yearly
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- ...Our client a growing medical device organisation currently seeks a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist will be responsible for all regulatory activities including product certification and compliance, and for supporting...Regulatory
- ...applications, then please tick this box If you are having difficulty you can always email your cv to ****@*****.*** Regulatory Affairs Manager Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes...Regulatory
- ...site management on key lagging and leading indicators for the site. Manage the incident investigation process on site and report to regulatory and corporate bodies as required. Coordinate with operations teams to ensure corrective actions are identified and implemented....Regulatory
- ...Job Title: Director of Quality Assurance & Regulatory Affairs Location: Galway, Ireland (or hybrid/remote as applicable) Department: Quality & Regulatory Reports To: Chief Operating Officer / CEO Role Overview We are seeking a highly experienced Director...RegulatoryRemote workHybrid work
- ...perform routine analytical testing as assigned and accurately document test results, ensuring compliance with all quality system and regulatory requirements. Key Responsibilities: Demonstrate a primary commitment to patient safety and product quality. Understand and...Regulatory
- ...Ensure that all procedures relating to any aspect of manufacturing are fully implemented and adhered to, in line with customer and regulatory expectations. Recommend and implement improvements to standards and foster a culture of continuous improvement in production and...RegulatoryFlexible hours
- ...you to ensure that the engineering function runs smoothly on time, within budget, adhering to quality and safety standards, in full regulatory compliance.Effective maintenance requires collaboration across teams and departments. Promoting a culture of safety and efficiency within...RegulatoryFull timeFor contractorsImmediate startShift work
- ...subject matter experts, and collaborate with internal departments to ensure that training initiatives align with business goals, meet regulatory requirements, and foster a culture of continuous learning and improvement. What’s important: Proven track record as a Training...Regulatory
- ...planners, and contractors. # Oversee project planning, budgeting, risk management, scheduling, and reporting. # Engage with clients, regulatory authorities, landowners, and other stakeholders. # Ensure compliance with health and safety, environmental, and planning...RegulatoryFor contractors
- ...operations here in Galway. The Role: To ensure that products and manufacturing processes comply with all relevant quality, regulatory, and industry standards. This role will support and enhance the Quality Management System (QMS), ensuring adherence to regulations such...RegulatoryPermanent employment
- ...regulations: ISO 10993 & ISO 18562 What You’ll Do: Lead Biocompatibility & Microbiology Strategy: Define testing strategies, ensure regulatory compliance, and drive innovation in materials selection. Ensure Compliance & Risk Management: Stay ahead of evolving regulatory...RegulatoryFull time
- ...processes, contributing to the delivery of medical devices that change lives. Responsibilities: Ensure compliance to all applicable regulatory standards and current GMP procedures and practices. Perform product defect analysis. Routine final functional testing, product...Regulatory
- ...capabilities to join the executive team. This is a pivotal role where you will shape and execute the company's quality strategy, oversee regulatory compliance, and drive operational excellence as the business grows both domestically and internationally. Key Responsibilities...Regulatory
- ...teams in design protocols to ensure that new products/ product changes are adequately evaluated/tested to guarantee compliance to all regulatory standards Collaborates with engineering and manufacturing functions to ensure quality standards are in place Devises and...RegulatoryHybrid work
- ...considered medium in scale and moderately complex. Directs and influences the preparation of documentation to support high quality regulatory submission dossiers. Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed....Regulatory
- ...overall equipment effectiveness and efficiency. Ensure that all Engineering work and designs are carried out to appropriate GMP, QA/Regulatory Authority standards and Environmental Health and Safety standards. Support the development of new processes in conjunction with...Regulatory
- ...Engineer II as they expand operations. The Role: This position requires an experienced and proven track record in Quality and Regulatory control of medical devices. This role will focus on ensuring product quality during early development phases through to commercial....Regulatory
- ...with Controls and Software Development groups to develop software specifications and Controls Algorithms. Co-ordinate any required regulatory testing of Electrical/Electronic solutions at external agencies as required per regulatory standards. Develop and manage...RegulatoryPermanent employment
- ...product development and innovation processes and procedures incorporating industry best practices and in compliance with appropriate regulatory requirements. Develop state-of-the-art understanding of relevant products and processes. Develop product and test...Regulatory
- ...: Ensuring all project activities meet the highest standards of quality, safety, and environmental compliance (QMS/EMS/OHSAS). Regulatory Compliance : Overseeing adherence to legal and statutory obligations, including Health & Safety and BCAR requirements. Financial...RegulatoryWork at office
- ...Develop and implement information management strategies for rail projects. Ensure compliance with BIM, ISO standards, and relevant regulatory frameworks. Coordinate and manage project documentation, including data storage, retrieval, and archiving. Support the design...Regulatory
- ...Multi-Criteria Assessments, and technical evaluations. You'll also be responsible for compiling specifications and tender documents. Regulatory Compliance: Prepare all necessary planning application documents. Team Collaboration: Coordinate seamlessly with...RegulatoryFor contractors
- ...Senior Quality Engineer you will play a critical part in ensuring that medical device products continue to meet the highest quality and regulatory standards throughout the full product lifecycle. Responsibilities: Support sustaining engineering projects by providing Design...RegulatoryFixed term contract
- ...solutions. Communicate validation results and progress to management. As required, prepare summaries of validation testing for regulatory submissions and present validations to regulatory agencies. Qualifications & Experience: Bachelor's degree in an engineering,...RegulatoryContract work
- ...1 Year + PQE – Various firms Solicitors, Associates, Senior Associates – Planning & Environmental – NQ to 7 Years PQE PUBLIC, REGULATORY & INVESTIGATIONS Associates – International Firm – Dublin – 1 to 4 year PQE Senior Associates – Irish & International Firms...RegulatoryRemote workHybrid work
- ...engineering vision for a breakthrough device Oversee and scale R&D and product development efforts Collaborate with clinical, regulatory, and commercial teams to bring solution to market Build and mentor a high-performing technical team Play a key role in strategic...Regulatory
- ...Develop and maintain operational processes and procedures incorporating industry best practices and in compliance with appropriate regulatory requirements. # Perform process analysis and identify areas for improvement, recommending and implementing solutions to enhance productivity...Regulatory
- ...planning. Auditing: Lead and manage audit engagements for a variety of clients. Ensure compliance with auditing standards and regulatory requirements. Identify and address areas of risk and provide recommendations for improvements. Insolvency: Manage...Regulatory
- ...assurance efforts across our clients’ critical systems. You'll act as a key advisor to IT, Operations, and QA teams, ensuring systems meet regulatory and quality standards (21 CFR Part 11, EU MDR, 21 CFR 820). This is a dynamic, hands-on role supporting both enterprise IT and...RegulatoryFor contractors
- ...Responsibilities Lead the research, design, and development of new medical devices, taking into consideration usability, safety, and regulatory requirements. Collaborate with cross-functional teams including product managers, engineers, and clinicians to ensure that...Regulatory