Overview The primary role of the Senior Regulatory Affairs Specialist is to assist in the running of the Regulatory Affairs department by providing input into: regulatory strategies, performing activities associated with…
Skills: Regulatory affairs, Medical device regulations, ISO standards, FDA regulations, Regulatory submissions
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Staff Supply Logistics Analyst to join our Warehouse & Logistics team. Thi…
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
Skills: Mechanical Engineering, Fluidics, Test Rigs, Verification And Validation, Characterisation
Why Join DACHSER? At DACHSER, we’re a global family powering over 83 million shipments every year—from fashion to life-saving medical supplies. Ranked among the world’s top logistics providers, we don’t just move goods—w…
Skills: Logistics planning, Route optimization, Team leadership, Data analysis, Transportation management
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
Skills: High-speed Data Converters, RF Systems Design, Mixed-signal Systems, Embedded C, Python
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
Skills: SolidWorks, CAD, 3D Printing, Injection Molding, Microfluidics
The Apprenticeship programme is crafted to provide apprentices with the required knowledge, skills, and competence to perform as a qualified craftsperson. Under the mentorship of expert technicians, the Apprentice is pri…
Apprenticeship Programme – Facilities (OEM Apprenticeship) The Apprenticeship programme is crafted to provide apprentices with the required knowledge, skills, and competence to perform as a qualified craftsperson. Workin…
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
Skills: Medini Analyze, Functional Safety, FMEDA, FTA, ISO 26262
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
Skills: Program Management, Embedded Software, Firmware Development, RTOS, SoC Enablement
Are you a Validation Engineer looking to work on cutting-edge pharmaceutical and biotech projects in Ireland? CAI is seeking a QA Validation Engineer to support qualification and validation activities for laboratory and …
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
Skills: Product Security, Security Assurance, Threat Analysis, Secure Development Life Cycle, SoC Security Architecture
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior IT Applications Analyst — QC Lab Systems to join our IOP…
Skills: QC Lab Systems, GxP Compliance, 21 CFR Part 11, Change Control, System Configuration
About Analog Devices Analog Devices, Inc. (NASDAQ: ADI) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, AI, and…
Skills: Project Management, Program Management, Planning, Execution, Stakeholder Coordination
Maintenance Electrician Application Deadline: 18 August 2026 Department: Operations Employment Type: Permanent - Full Time Location: Limerick Reporting To: Terminal Manager Description Our Business px PEOPLE, their commi…
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a QA Compliance Specialist to join our QA Compliance & Quality Systems team.…
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Full-time
bachelor degree
Posted 13d ago
Apply by Jul 30
~40 hrs/week
Responsibilities
The Senior Regulatory Affairs Specialist will manage regulatory strategies and submissions to ensure medical devices meet global standards and market requirements. They will also provide guidance to functional units, mentor team members, and maintain compliance records for all assigned products.
Requirements
Candidates should hold a third-level qualification in Science or Quality Engineering and possess approximately 5 years of experience in a regulated industry. Proficiency in medical device standards, such as ISO and FDA regulations, is essential for this role.
Full job description
Overview
The primary role of the Senior Regulatory Affairs Specialist is to assist in the running of the Regulatory Affairs department by providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the functional areas.
Find out more about Cook Medical here
Responsibilities
Assists in the running of the Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.
Maintains an excellent understanding of the global medical device regulations.
Maintains a thorough understanding of the regions and/or products assigned to the team.
Works to improve the function of the Regulatory Affairs Department.
Understands the progress of the RA team on assigned tasks, and removes roadblocks.
Provides support to the RA team members to complete assigned tasks.
Mentors and trains new RA team members.
Communicates country/region specific regulatory requirements of the regions they are assigned to the RA team
Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed and collaborates with their assigned regulatory specialists on same in any jurisdiction.
Ensures the clinical requirements of the product are adequately addressed.
Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that jurisdiction.
Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable).
Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market and updates same on approval status in target markets.
Ensure the outputs from the individual functional units (engineering, marketing etc.) meet the applicable regulatory requirements.
Communicates status of projects / submissions directly to RA Management and other stakeholders as required.
Communicates directly with regional regulatory agencies / notified bodies/distribution partners/Cook affiliates to ensure product clearances are achieved in a timely manner.
Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
Provides support to currently marketed products as necessary including input on change requests, regulatory restrictions
Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
Provides regulatory support to Cook functional units such as the SSC, tenders, customer quality and distribution.
Is a delegate for other Regulatory Affairs Specialists, Senior Regulatory Scientist and the Team Lead, Regulatory Affairs.
Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.
Perform additional duties as assigned.
Qualifications
Third level Qualification preferably in Science/Quality Engineering
5 years’ experience in a regulated industry in a similar role is desirable.
Ideally have knowledge of requirements in MDSAP countries.
Knowledge of requirements in other jurisdictions where required.
Knowledge of medical device quality standards/practises or similar regulated industry.
Good communication and inter-personal skills.
Proven problem-solving skills.
Good computer skills including knowledge of Microsoft®
Proven organisational skills.
High self-motivation.
Willingness and availability to travel on company business.
At Cook, we are building our future on Invention, Connection, People, and Community.
As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device.
Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.
Offices: 750 N Daniels Way, Bloomington, Indiana 47404, US · 8 Fleming Road, Wan Chai, HK · 300 E Elm St, Canton, IL 61520, US · 1186 Montgomery Ln, Vandergrift, PA 15690, US · O'Halloran Road, Limerick , Munster, IE
medical device manufacturingHealth CareRestaurantsFertilityMedical DeviceHardwareRetailFood and BeverageMedicalManufacturing
How many Manufacturing jobs are open in Limerick, Ireland right now?
There are currently 133 open manufacturing positions in Limerick, Ireland listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Limerick, Ireland?
Companies currently hiring include Analog Devices, Regeneron, Johnson & Johnson Innovative Medicine, Cook Medical, CAI, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Limerick, Ireland?
Yes — 15 of the 133 open manufacturing positions offer remote or hybrid work (0 remote, 15 hybrid).
How do I apply for Manufacturing jobs in Limerick, Ireland?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.