Our client, a leading provider of advanced automation solutions to the medical device sector, is seeking an experienced Principal Automation Engineer (Controls) to join their growing team in Galway. This is a senior‑level individual contributor role within a well‑established multi‑disciplinary engineering environment, offering the opportunity to work on the design, development, and commissioning of high‑spec automated equipment from concept through to full implementation. The successful candidate will be a technical expert in machine control systems, with deep experience in PLC/HMI programming and a strong background in the design and delivery of complex automated machinery. This is an excellent opportunity to play a key role in the development of cutting‑edge automation solutions used in the manufacture of life‑saving medical technologies. Responsibilities include but are not limited to: Design and integrate control system software for automated machines, including PLCs, Robotics, Motion Control, HMI, SCADA, and Vision systems . Develop, test, commission, and support machine control software across the full project lifecycle. Support the preparation of validation documentation required for regulated industries, including URS, FDS, FAT , and related documents. Specify and evaluate control system components to ensure robust and reliable machine performance. Collaborate closely with multidisciplinary project teams including mechanical, electrical, software, and project engineering functions. Provide technical direction, guidance, and support to other members of the controls engineering team. Contribute to problem‑solving, troubleshooting, and continuous improvement activities across automation projects. Ensure all automation solutions are developed in line with quality, safety, and regulatory expectations. Job Requirements: Minimum 10 years’ experience in equipment automation , with strong expertise in PLC and HMI programming . Experience with Allen Bradley platforms is strongly preferred. Expert knowledge of automated machine design, specification, and development . Proven experience working with robotics, motion control, machine vision, and pneumatic systems . Strong understanding of automation systems in a regulated manufacturing environment , ideally within medical device or similar high‑spec sectors. Ability to support technical documentation and validation requirements for regulated industries. Key Skills and Attributes: Excellent communication and interpersonal skills. Proactive, energetic, and solutions‑focused approach. Strong organisational skills with the ability to manage multiple priorities. Quality‑minded with a strong analytical and problem‑solving mindset. Comfortable working as part of a multifunctional project team. Full clean driving licence and willingness to travel occasionally. Full‑time, permanent role based in Galway. Opportunity to join a growing and technically advanced engineering team. Work on innovative, high‑tech automation projects within the medical device sector. Immediate interviews available for suitable candidates. #J-18808-Ljbffr
A leading recruitment firm in Ireland seeks a Senior Regulatory Manager to oversee compliance and regulatory strategies within an innovative IVD manufacturer. This role involves leading a regulatory team, managing compliance documentation, and ensuring adherence to international regulations. The ideal candidate has over 5 years of experience in the Medical Device sector and strong knowledge of ISO 13485 and EU regulations. This is a unique opportunity to contribute to a forward-thinking company focusing on diagnostic innovation. #J-18808-Ljbffr
Overview Pale Blue Dot® Recruitment – Ireland’s go-to STEM talent partner – is recruiting on behalf of an innovative IVD manufacturer seeking a Regulatory Manager to lead their regulatory function and ensure ongoing compliance across global markets. This is a senior-level opportunity for an experienced regulatory professional who thrives in a fast-paced, quality-driven environment. Reporting to the Chief Operations Officer, you will lead a high-performing regulatory team and manage global compliance strategies to support the company’s current and future product portfolio. Key Responsibilities include but are not limited to: Responsibilities Lead, coach, and develop a team of regulatory professionals to deliver results. Oversee implementation of regulatory strategies in line with evolving requirements. Manage and maintain technical documentation for Class A and B IVD products. Drive post-market surveillance and risk management processes. Coordinate vigilance reporting for CE-IVD and other international markets. Maintain and expand regulatory certifications in existing and new territories. Collaborate cross-functionally with R&D, Manufacturing, and Quality on compliance and product strategies. Stay current on international regulatory requirements (EU IVDR, MDR, etc.) and communicate implications company-wide. Act as Deputy Person Responsible for Regulatory Compliance (PRRC), when needed. Qualifications BSc in Molecular Biology or related scientific discipline. Minimum 5 years\' regulatory experience within the Medical Device or IVD sector. At least 2 years\' experience leading or supervising regulatory personnel. Expert knowledge of ISO 13485 and EU IVDR/MDR . Strong documentation, organisational and interpersonal skills. Ability to manage multiple projects and competing priorities with precision. Experience with Software as a Medical Device (SaMD) and associated standards. Proven experience liaising with Notified Bodies or international Regulatory Authorities . This is a rare opportunity to join a dynamic, forward-thinking company at the forefront of diagnostic innovation. If you're a proactive leader ready to make an impact, apply now. Pale Blue Dot® Recruitment – Experts in STEM Workforce Solutions #J-18808-Ljbffr
