Regulatory Affairs Specialist 2

Overview The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates,...

Overview The opportunity Get started on an exciting and meaningful career path with Cook Medical. We love passionate people with great ideas. Our 18-month graduate program in Limerick, Ireland provides tailored opportunities to use your qualifications and launch your career while learning and developing new skills. About Cook Medical Since 1963, Cook...

Overview Device Compliance/NPI: The primary role of the Senior Regulatory Scientist is to assist in the running of the regulatory affairs 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...

Overview Device Compliance/NPI: The primary role of the Senior Regulatory Scientist is to assist in the running of the regulatory affairs 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...

Senior Regulatory Officer Industry: Medical Device Department: Regulatory Affairs Role Summary – Major Activities: 1. Provide coaching and support to all employees on the regulatory team. 2. Ensure employees understand their duties/delegated tasks. 3. Prepare and maintain IVDR compliant technical files utilising information from cross functional...

Overview The primary function of this position is to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices, specifically providing oversight in method development and validation, compendial method verification and transfer, specification/acceptance...

Overview The Manufacturing Engineer 2, New Product Introduction will be responsible for key activities within New Product Introduction. Key activities will include leading projects to either introduce new products or support and improve existing products. More specific details are listed below. Reporting to: Manager, Manufacturing Engineering Find out...

Overview The Manufacturing Engineer 2, New Product Introduction will be responsible for key activities within New Product Introduction. Key activities will include leading projects to either introduce new products or support and improve existing products. More specific details are listed below. Reporting to: Manager, Manufacturing Engineering...

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich...

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties 1. Execute cycle development, cleaning validation and PQ of equipment. 2. Writing and adhering to...

Within this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g. HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with...

Overview The primary responsibility of this role is to provide Quality Assurance support as required within Cook Medical Europe Ltd. (CMEU). This includes completing internal audits and maintaining the internal audit system; providing support to software validation, change requests, non-conformance issues, and the Company’s corrective and preventive...

360 Search are delighted to recruiting for a Group Pensions Specialist opportunity with a highly regarded Financial Service broker based in the Mid-West. Our client is hugely experienced in all areas of Personal Financial Planning, as well as having the necessary qualifications required to provide advice to all new and existing clients. Their aim is...

The Quality System Specialist participates in maintaining site compliance of operations in accordance with mandated regulatory requirements and site expectations. The Quality Systems Specialist provides oversight of the Quality Management System (QMS) implementation and use. This position may also support global elements of the QMS and lead or participate in...

Our client, a leading global medical devices company, is now seeking a Chemist to join their team in Limerick. The primary function of this position is to lead and/or participate in projects focused on developing strategy with respect to chemistry, manufacturing, and controls (CMC) of combination drug devices, specifically providing oversight in method...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

Quality Specialist & Deputy RP Our client, a healthcare service provider, is currently recruiting for a Quality Specialist & Deputy RP to join their team on a permanent basis. As Quality Specialist & Deputy RP, you will support the business's QMS along with the development and implementation of processes and systems to maintain compliance with the GxP...

The Principal GMP Data Governance Specialist plays a pivotal part in ensuring that Regeneron's Data Governance (DG) systems and practices meet the highest standards of regulatory and industry compliance. You will beresponsible for providing specialised knowledge and expertise in the design of (DG) frameworks, policies and procedures that are aligned with...

Overview The Manufacturing Engineer 2 (Test Method Validation) Reporting to: Manager, Manufacturing Engineering Responsibilities - Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards. - Validate and implement medical device manufacturing processes as assigned. - Identify equipment/fixture installation...

Overview The primary responsibility of this role is to provide Quality Assurance support as required within Cook Medical Europe Ltd. (CMEU) This includes completing internal audits and maintaining the internal audit system; providing support to software validation, change requests, non-conformance issues and the Company's corrective and preventive action...