<h3 data-start="351" data-end="379">Regulatory Affairs Specialist Contract Galway Position Overview:</h3>This role is responsible for planning, coordinating, and executing regulatory submissions for the US FDA, EU notified bodies, and global product registrations. It also involves maintaining ongoing compliance with regulatory approvals and performing change impact assessments.<h3 data-start="664" data-end="695">Key Responsibilities:</h3><ul data-start="697" data-end="1780"><li data-start="697" data-end="808">Support regulatory activities with a focus on Coronary Therapy devices as part of a collaborative team.</li><li data-start="809" data-end="956">Prepare and submit regulatory documentation for U.S. and EU markets, including PMAs, CE Marking submissions, and internal regulatory files.</li><li data-start="957" data-end="1106">Serve as a regulatory representative on cross-functional product development teams, offering strategic guidance throughout the product lifecycle.</li><li data-start="1107" data-end="1210">Review and approve design and manufacturing changes to ensure compliance with relevant regulations.</li><li data-start="1211" data-end="1292">Support product registrations and approvals across international markets.</li><li data-start="1293" data-end="1444">Contribute to continuous improvement initiatives aligned with the organization's Quality Management System and applicable regulatory standards.</li><li data-start="1445" data-end="1551">Collaborate on enhancing team practices and promoting knowledge sharing and regulatory best practices.</li><li data-start="1552" data-end="1638">Participate in sustaining activities under product lifecycle management processes.</li><li data-start="1639" data-end="1780">Assist in preparing for and participating in regulatory inspections and audits (e.g., FDA, EU Notified Bodies, national authorities).</li></ul><h3 data-start="1787" data-end="1825">Qualifications &amp; Experience:</h3><ul data-start="1827" data-end="2347"><li data-start="1827" data-end="1901">Degree (Level 8 or equivalent) in a Science or Engineering discipline.</li><li data-start="1902" data-end="1947">Strong interpersonal and teamwork skills.</li><li data-start="1948" data-end="2032">Excellent verbal and written communication, including technical writing ability.</li><li data-start="2033" data-end="2107">Proven ability to manage multiple priorities and projects effectively.</li><li data-start="2108" data-end="2192">Prior experience in Regulatory Affairs or Design Assurance is desirable.</li><li data-start="2193" data-end="2347">Familiarity with drug-device combination products or manufacturing processes in the medical device or pharmaceutical industry is an advantage.</li></ul>

Regulatory Affairs Specialist

Job Title - Applications Engineer&nbsp; Reports to - Engineering Manager&nbsp; Type: Long Term Contract&nbsp; Summary&nbsp; Your role will encompass maintaining software solutions, fault finding issues, reviewing code, supporting new automated systems and training engineers on code review. Key Areas of Responsibility:&nbsp; <ul><li>Technical Support &amp; Troubleshooting: Provide ongoing support to users, diagnosing and resolving application-related issues promptly.</li><li>Performance Monitoring: Regularly assess application performance, identifying areas for optimization and implementing necessary enhancements.</li><li>Provide Applications Technical leadership from an engineering perspective.</li><li>Review code on old machines and insert comments on blocks.</li><li>Train engineers on code troubleshooting techniques.</li><li>All other duties as assigned</li></ul> Qualifications, Knowledge &amp; Skills:&nbsp; <ul><li>Level 8 Degree in Mechanical Engineering or relevant discipline or equivalent technical experience is required.</li><li>Has minimum of 4 years&rsquo; experience in a manufacturing environment.</li><li>Strong communication and influencing skills with both internal and external.</li><li>Proficiency in programming languages such as Siemens, Allen Bradley, Rockwell Studio, Mitutibi, Beckhoff, Fanuc and ABB controls.</li><li>Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment</li><li>Good knowledge on how to access panels and access the software system.</li><li>Demonstrable strong analytical &amp; problem solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced environment</li><li>Demonstrable ability to work autonomously</li><li>A team player, with a flexible approach.</li></ul>

Applications Engineer - PLC

Electrical Engineering Consultant Limerick&nbsp; Contract role&nbsp; Position Summary: Seeking an experienced Electrical Engineer to provide technical design support for a new Process Area CAPEX project. The role will also involve supporting smaller capital initiatives and ongoing site operations. <h3 data-start="380" data-end="409">Key Responsibilities:</h3><ul data-start="411" data-end="1726"><li data-start="411" data-end="636">Design and maintain Low Voltage (LV) systems (e.g., lighting, general services, UPS, protection settings including arc flash) and Extra-Low Voltage (ELV) systems (e.g., fire alarm, data points, building automation).</li><li data-start="637" data-end="724">Manage and execute small-scale projects focused on electrical systems infrastructure.</li><li data-start="725" data-end="823">Support the design review, site acceptance, and installation processes for electrical equipment.</li><li data-start="824" data-end="903">Prepare and maintain electrical drawings and related technical documentation.</li><li data-start="904" data-end="1008">Specify and design cGMP-compliant electrical and instrumentation (E&amp;I) equipment and process controls.</li><li data-start="1009" data-end="1075">Oversee electrical systems integrated with business IT networks.</li><li data-start="1076" data-end="1183">Collaborate with the validation team by preparing design documentation and supporting protocol execution.</li><li data-start="1184" data-end="1297">Participate in investigations of equipment anomalies, including power quality events and control system issues.</li><li data-start="1298" data-end="1385">Prepare engineering evaluations and manage modification change control documentation.</li><li data-start="1386" data-end="1475">Supervise electrical contractors, ensuring work is completed to the required standards.</li><li data-start="1476" data-end="1571">Prepare risk assessments, method statements, and other Health &amp; Safety-related documentation.</li><li data-start="1572" data-end="1643">Promote and enforce a clean, safe, and compliant working environment.</li><li data-start="1644" data-end="1726">Ensure compliance with applicable regulations, standards, and internal policies.</li></ul><h3 data-start="1733" data-end="1769">Qualifications &amp; Experience:</h3><ul data-start="1771" data-end="1908"><li data-start="1771" data-end="1841">Bachelor&rsquo;s degree in Electrical Engineering or a related discipline.</li><li data-start="1842" data-end="1908">Minimum of 4 years of relevant experience in a similar role.</li></ul>

Electrical Engineer

Project Manager - Castlebar - 12 month contract&nbsp; Our client is a manufacturing provider to medical device and pharma and is looking for a Project Manager for 12 months to plan, lead and execute project's ensuring alignment with organizational goals while managing stakeholder relationships.&nbsp; In this role you will :&nbsp; Lead the planning and execution of projects from initiation to closure. <ul><li>Define project scope, objectives, deliverables, timelines and budgets.</li><li>Develop and maintain detailed project plans, schedules, Gantt charts and documentation.</li><li>Manage relationships with external parties, vendors, contractors and suppliers.</li><li>Co-ordinate and liaise with cross functional teams to ensure project success.</li><li>Identify, assess, and mitigate project risks and issues.</li><li>Monitor project progress, track KPI&rsquo;s and report updates to stakeholders.</li><li>Manage stakeholder communications and ensure alignment across teams.</li></ul>Ideally you will have:&nbsp; <ul><li>Bachelor&rsquo;s degree in Business, Management, Engineering or a related field.</li><li>Proven experience as a Project Manager or similar role (ideally in Manufacturing)</li><li>Strong leadership, organisational and problem-solving skills.</li><li>Proficiency in project management tools, e.g. MS Project, Jira, etc)</li><li>Ability to manage multiple projects simultaneously under tight deadlines.</li><li>Strong financial and budget management skills.</li></ul> For further information on this role in please contact on Regina Carroll&nbsp; on 086 0100 903 or jobs@hero.ie Check out all our open jobs on our HERO Recruitment website &ndash; <a href="https://www.hero.ie/">https://www.hero.ie/</a> Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review

Project Manager

We design the technology that powers the world around us&mdash;and we&rsquo;re looking for skilled Electro-Mechanical Technicians to join our growing team in Ennis.As part of a strong global team, you&rsquo;ll work with cutting-edge automated systems in a supportive environment built on trust, empowerment, and growth.What You&rsquo;ll Do:<ul data-start="506" data-end="862"><li data-start="506" data-end="573">Maintain and improve high-speed automated production equipment.</li><li data-start="574" data-end="681">Troubleshoot and repair mechanical and electronic systems, including PLCs, sensors, and circuit boards.</li><li data-start="682" data-end="776">Support production teams with changeovers, preventive maintenance, and equipment upgrades.</li><li data-start="777" data-end="862">Contribute to projects for new equipment installation and continuous improvement.</li></ul>What We&rsquo;re Looking For:<ul data-start="894" data-end="1186"><li data-start="894" data-end="986">2+ years&rsquo; experience in electro-mechanical maintenance within high-volume manufacturing.</li><li data-start="987" data-end="1058">A Certificate or Diploma in an electro-mechanical or related field.</li><li data-start="1059" data-end="1137">Strong problem-solving skills and ability to read schematics and drawings.</li><li data-start="1138" data-end="1186">Flexible, team-oriented, and safety-focused.</li></ul>Why Join Us?<ul data-start="1207" data-end="1498"><li data-start="1207" data-end="1281">Be part of a multi-billion-dollar global leader in semiconductors.</li><li data-start="1282" data-end="1346">Access world-class training and career development programs.</li><li data-start="1347" data-end="1427">Thrive in a workplace recognized for diversity, respect, and excellence.</li><li data-start="1428" data-end="1498">Enjoy the stability and opportunity to grow with us long-term.</li></ul>

Automation Technician 

Manufacturing Engineer&nbsp;Location: GalwayJob Type: Full-Time Contract RoleJob Summary: As a Manufacturing Engineer II, you will play a crucial role in the production of self-expanding Stents products. You will leverage your technical expertise, problem-solving abilities, and validation experience to ensure the efficiency and quality of our manufacturing processes. Your efforts will directly impact the improvement of our processes and the successful completion of our projects.Key Responsibilities:<ul><li>Technical Expertise: Apply advanced engineering principles to support and improve manufacturing processes within the medical device sector.</li><li>Problem Solving: Identify and resolve manufacturing issues to maintain product quality and production efficiency.</li><li>Validation Experience: Conduct and document validation activities to ensure compliance with regulatory requirements and quality standards.</li><li>Process Improvement: Continuously evaluate and enhance manufacturing processes to optimize productivity and reduce costs.</li><li>Project Management: Lead and participate in project teams, ensuring timely completion of deliverables within budget.</li><li>Teamwork: Collaborate effectively with cross-functional teams including R&amp;D, Quality, and Operations to achieve common goals.</li><li>Communication Skills: Clearly and effectively communicate technical information to team members, stakeholders, and management.</li></ul>Qualifications:<ul><li>Minimum of 3 years of experience in a manufacturing engineering role, preferably within the medical device or related industry.</li><li>Strong technical background with a proven track record in problem-solving and process improvement.</li><li>Hands-on experience with validation processes and documentation.</li><li>Excellent project management skills with the ability to manage multiple projects simultaneously.</li><li>Effective teamwork and interpersonal skills.</li><li>Strong verbal and written communication skills</li></ul>

Manufacturing Engineer (Multiple roles) 

I specialise in talent acquisition for diverse industries across Ireland. With a robust experience spanning over three decades, HERO Recruitment has earned a stellar reputation for our unwavering passion and commitment to excellence.
Our client portfolio is broad, covering sectors such as medical devices, pharmaceuticals, manufacturing, IT, and more. Armed with extensive connections, I can confidently locate the perfect match for you.
However, let's shift the focus to you &ndash; your dreams and goals are my driving force. Beyond being a recruiter, I am your dedicated partner, ready to guide you through every step of your journey. Together, we will navigate through various opportunities and transform your career aspirations into reality.
Join the HERO Recruitment family today, and let's co-create a success story that is uniquely yours. Together, we will make a substantial impact in the industry. Are you ready? Let's make it happen.

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Applications Engineer - PLC

Recruitment Consultant

Applications Engineer - PLC

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