A leading medical device multinational in Limerick is seeking a Senior Regulatory Affairs Specialist to manage regulatory affairs processes. The ideal candidate will have extensive experience in regulatory compliance within the medical device industry, particularly with ISO13485 and FDA standards. Responsibilities include preparing regulatory submissions, ensuring compliance with various jurisdictions, and communicating with regulatory agencies to achieve timely product clearances. Strong communication and problem-solving skills are essential for success in this role. #J-18808-Ljbffr
An opening for a Senior Regulatory Affairs Specialist has arisen within a renowned Limerick based medical device multinational. The successful candidate will assist in the running of the regulatory affairs by providing input into the required functional areas. Key Responsibilities Assists in the running of the regulatory affairs programmes in accordance with internal procedures and regulatory requirements. Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required and other jurisdictions as required. Understands the progress of the RA team on assigned tasks. Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed. Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction. Develops global regulatory strategies in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices. Ensures the biocompatibility and clinical requirements of the product are adequately addressed. Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner. Maintains a system for registration information (license numbers, expiration dates etc.) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability. Qualifications and Experience Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable. Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required. Knowledge of requirements in other jurisdictions where required. Knowledge of medical device quality standards/practices or similar regulated industry. Good communication and inter-personal skills. Proven problem-solving skills. Approved External Auditor. #J-18808-Ljbffr
A leading engineering firm in Dublin is looking for an Offshore Lead Cables Engineer to oversee the delivery of submarine cable projects for offshore wind and grid developments in Ireland and the UK. You will be responsible for engineering leadership, project execution, and coordinating with a range of stakeholders, including suppliers and contractors. A degree in Electrical Engineering and 7–10+ years of relevant experience in HV/EHV submarine cable engineering is required. This role also involves risk management, quality assurance, and compliance with industry standards. #J-18808-Ljbffr
We are seeking an experienced Offshore Lead Cables Engineer to support the delivery of submarine cable packages for offshore windfarm and grid development projects across Ireland and the UK. This role is critical in ensuring the successful design, procurement, installation, and commissioning of HV/EHV cable systems, delivered safely, on time, and within budget. You will play a key role in technical leadership, project execution, and stakeholder coordination, working across multidisciplinary teams and engaging with suppliers, contractors, and industry experts. Key Responsibilities Engineering & Technical Leadership Lead end-to-end engineering of HV/EHV submarine cable systems (66kV–400kV) Develop and review cable designs (conductor, insulation, armouring, sheath) Perform thermal, electrical, and mechanical analyses (ampacity, ratings) Define technical specifications and acceptance criteria Project Delivery & Assurance Support FEED and early‑stage project development Oversee design, manufacturing, installation, and commissioning phases Manage FAT/SAT testing and ensure compliance with standards (IEC, CIGRE, DNV) Coordinate interfaces across suppliers, contractors, and internal teams Installation & Marine Operations Provide input into route engineering, burial strategies, and protection systems Support offshore readiness, operations, and risk assessments Risk, Quality & HSE Lead risk assessments, failure mode analysis, and mitigation strategies Ensure quality assurance and compliance with project specifications Support root cause investigations and HSE integration Stakeholder & Supply Chain Management Collaborate with OEMs, contractors, and industry stakeholders Support tender evaluations, contract negotiations, and supplier selection Represent projects in technical reviews and industry forums Requirements 7–10+ years’ experience in HV/EHV submarine cable engineering Strong expertise in cable design, installation, and testing Experience in offshore wind, transmission, or large infrastructure projects Strong stakeholder management and commercial awareness Degree in Electrical Engineering (Chartered status preferred) #J-18808-Ljbffr
Senior Regulatory Affairs Specialist An opening for a Senior Regulatory Affairs Specialist has arisen within a renowned Limerick based medical device multinational. The successful candidate will assist in the running of the regulatory affairs by providing input into the required functional areas. Key Responsibilities Assists in the running of the regulatory affairs programmes in accordance with internal procedures and regulatory requirements. Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA 21CFR Part 820 as required and other jurisdictions as required. Understands the progress of the RA team on assigned tasks. Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed. Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction. Develops global regulatory strategies in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices. Ensures the biocompatibility and clinical requirements of the product are adequately addressed. Communicates directly with regional regulatory agencies / notified bodies to ensure product clearances are achieved in a timely manner. Maintains a system for registration information (license numbers, expiration dates etc.) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability. Qualifications and Experience Third level Qualification preferably in Science/Quality, 5 years experience in a regulated industry in a similar role is desirable. Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required. Knowledge of requirements in other jurisdictions where required. Knowledge of medical device quality standards/practices or similar regulated industry. Good communication and inter-personal skills. Proven problem-solving skills. Approved External Auditor. For more information and a full job spec please email your CV in the strictest confidence to the link provided Skills: Reg Affairs Regulatory Affairs Medical Devices ISO13485
A leading engineering consultancy in Dublin is seeking an experienced Project Manager to oversee small- to medium-scale projects within the pharmaceutical sector. The ideal candidate will have a degree in Engineering or Architecture and at least five years of relevant experience, particularly in building services. Responsibilities include managing project schedules, ensuring compliance with quality and safety standards, and collaborating effectively with multidisciplinary teams. Strong communication and organizational skills are essential. #J-18808-Ljbffr
The successful candidate will possess a solid understanding of mechanical systems, be familiar with Piping and Instrumentation Diagrams (P&IDs), and demonstrate broad knowledge of Civil, Structural & Architectural (CSA) and Electrical & Instrumentation (E&I) disciplines. This role involves working collaboratively with the Sustaining Capital and Site Services Team as a Project Manager, Project Engineer, or Program Manager , delivering small- to medium-scale projects within the pharmaceutical sector. The successful candidate will report directly to the Director of Projects for Sustaining Capital and Site Services. Responsibilities Broad technical knowledge of pharmaceutical equipment and facility installations Familiarity with full project lifecycles, from early concept and design development through to implementation and close-out Understanding of project governance, including progress tracking, change management, and reporting processes Commercial awareness relating to project performance and delivery outcomes Ability to coordinate and manage multidisciplinary project teams Strong commitment to health, safety, and environmental standards Capability to develop, manage, and maintain project schedules Knowledge of quality management systems and experience ensuring compliance with their requirements Self-motivation with the ability to foster teamwork and collaborate effectively with clients, design partners, and project stakeholders Contractual awareness relevant to the administration and delivery of pharmaceutical projects Qualifications & Experience Degree in Engineering, Architecture, or a relevant Commercial discipline Minimum of five years experience, supported by an engineering background and proven knowledge of building services within the pharmaceutical industry. Experience identifying, implementing, and complying with applicable safety, environmental, and quality standards, company procedures, policies, and regulatory requirements Demonstrated experience delivering construction or capital projects Excellent communication, coordination, and organisational skills. #J-18808-Ljbffr
Location: Dublin / Cork Role The successful candidate will possess a solid understanding of mechanical systems, be familiar with Piping and Instrumentation Diagrams (P&IDs), and demonstrate broad knowledge of Civil, Structural & Architectural (CSA) and Electrical & Instrumentation (E&I) disciplines. This role involves working collaboratively with the Sustaining Capital and Site Services Team as a Project Manager, Project Engineer, or Program Manager, delivering small- to medium-scale projects within the pharmaceutical sector. Responsibilities Broad technical knowledge of pharmaceutical equipment and facility installations Familiarity with full project lifecycles, from early concept and design development through to implementation and close-out Understanding of project governance, including progress tracking, change management, and reporting processes Commercial awareness relating to project performance and delivery outcomes Ability to coordinate and manage multidisciplinary project teams Strong commitment to health, safety, and environmental standards Capability to develop, manage, and maintain project schedules Knowledge of quality management systems and experience ensuring compliance with their requirements Self-motivation with the ability to foster teamwork and collaborate effectively with clients, design partners, and project stakeholders Contractual awareness relevant to the administration and delivery of pharmaceutical projects Qualifications & Experience Degree or equivalent qualification in Engineering, Architecture, or a relevant Commercial discipline Minimum of five years experience, supported by an engineering background and proven knowledge of building services within the pharmaceutical industry Experience identifying, implementing, and complying with applicable safety, environmental, and quality standards, company procedures, policies, and regulatory requirements Demonstrated experience delivering construction or capital projects Excellent communication, coordination, and organisational skills. Skills: Pharmaceutical Manufacturing Regulatory Requirements Capital Projects
A leading recruitment firm is seeking a professional to oversee health, safety, and environmental practices on construction projects. The ideal candidate will have over 5 years of experience in Life Science or Advanced Manufacturing. Key responsibilities include coordinating safety practices, ensuring compliance with regulations, and developing HSE training for staff. This role is based in Limerick, Ireland, where the candidate will work closely with project teams to deliver safe construction outcomes. #J-18808-Ljbffr
Reporting to the Safety Manager and Project HSE Director, Responsibilities Coordinate and oversee permit-to-work processes for construction activities within live operational environments. Support the safe delivery of construction projects through the implementation of effective Health, Safety, and Environmental (HSE) practices and requirements. Assist the Project HSE Manager and HSE Director in executing the project HSE programme while ensuring compliance with applicable legal and regulatory standards. Develop and implement project-specific HSE plans aligned with statutory obligations and recognised international standards (e.g., ISO 45001 and ISO 14001). Review contractors’ Safe Systems of Work, Risk Assessments, and Method Statements (RAMS) to ensure suitability and compliance. Apply organisational HSE management programmes through established project procedures and standards. Support incident investigations, including root cause analysis and the implementation of corrective and preventive actions. Prepare and distribute HSE reports for both internal teams and external stakeholders. Monitor HSE performance through inspections, audits, and performance reporting activities. Contribute to HSE performance improvement initiatives, action plans, and continuous improvement programmes. Develop and deliver site inductions and HSE training sessions for project personnel. Support workforce wellbeing initiatives, including wellbeing and safety culture programmes. Plan and deliver HSE awareness campaigns and events, such as Safety Week and other safety engagement initiatives. Qualifications Minimum 5 Years experience in Life Science or Advanced Manufacturing #J-18808-Ljbffr
