Overview: The Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR). The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical’s non-EU manufacturers. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the EU regulatory authorities. Responsibilities: Maintain an excellent understanding of the medical device regulations of the EU, (EMEA (Including UK, Switzerland) and EN ISO13485). Ensure a thorough understanding of the products they are assigned to from the relevant Cook Manufacturer. Work with the global project manager EU MDR and other global and local team members to successfully implement the requirements of the EU MDR at the office of the EU Authorised Rep CMEU and/or sister Cook companies as required. Ensure processes and procedures are put in place and maintained as part of the QMS to carry out the role of EU AR as per Article 11 of EU MDR. Maintain close contact and links with relevant Cook manufacturing sites and ensure contracts/Mandates are in place between the EU AR and Cook manufacturers that the EU AR represents. Liaise with and respond to requests for information and/or documentation/samples from Competent Authorities. Inform relevant CA’s of any reportable incidents and field safety corrective actions. Complete the EU AR obligations as outlined under Article 11 and 12 of EU MDR. Complete the EU AR obligations under MDD and per agreements. Monitor post-market surveillance as necessary. Identify and monitor legislative and regulatory activities, update processes and procedures as appropriate and report their potential impact on the company to local and global leadership as necessary. Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required. Serve as a liaison on regulatory issues between the Cook Manufacturer and the Office of EU Authorised Rep. Provide assistance to Cook UK (UKRP) and the Swiss Representative. Provide support to currently marketed products as necessary including input on change requests, PMS etc. Maintain and organise appropriate regulatory records to demonstrate compliance with applicable regulations. Provide regulatory support to Cook functional units such as the SSC, tenders, CMEU acting as import/distributor, customer quality and distribution partners. Provide support for regulatory audits. Perform additional duties as assigned. Act as RA change analyst. Be a delegate for the Regulatory Affairs Specialists 1 and 2 and Regulatory Scientist 2. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications: Third level qualification preferably in Science/Engineering or Law; 2-5 years’ experience in a regulated industry in a similar role desirable. Ideally have knowledge of requirements of European Medical Devices Regulation (EU-MDR), Regulation (EU) 2017/745, Medical Device Directive (93/42/EEC). Knowledge of relevant ISO, EU, FDA medical device standards regulations is desirable. Knowledge of medical device quality standards/practices or similar regulated industry. Good communication and inter-personal skills. Proven problem-solving skills. Good computer skills including knowledge of Microsoft Office. Proven organisational skills. High self-motivation. Approved External Auditor. Willingness and availability to travel on company business. #J-18808-Ljbffr
Overview: This role provides financial leadership to the Irish manufacturing site, with overall financial responsibility for the Irish manufacturing legal entity. The Plant Controller will have a strong understanding of the operational and financial performance of the plant and will partner with leadership to identify and drive improvements. Responsibilities include managing and driving improvements in the financial systems, including planning, product costing, and operational controlling. Taking global functional direction, the Plant Controller is a member of the CIRL senior management team. Responsibilities: Plays a key role in establishing the financial direction for the site, coordinates, consolidates, and analyses financial results, plans, and forecasts. Prepares financial analysis for various business opportunities and continuous improvement initiatives, accesses associated risks, and makes recommendations. Leads the month end close and forecast process, analyses and interprets results/cost trends, explains key variances, makes recommendations for action and ensures compliance with balance sheet reconciliation process. Supports the preparation of the annual R&D Tax credit submission process for the Irish Entity. Co-ordinates preparation and submission of specific IDA grants. Responsibility for liaison with external bodies including Statutory Auditors, Tax Authorities and other service providers as necessary. Works together with business partners in order to determine reporting needs and delivers clear and effective reports, KPIs, and presentations, utilizing a variety of software packages. Provides and analyses financial information in support of annual external audits. Partners with Procurement and Operations to maintain accurate and efficient inventory and coordinates periodic inventory counts and variance reconciliations. Contributes as a member of the global cost team that works to drive consistency and continuous improvement across the organisation. Manages cost team, including training, development, & performance management. Performs backup duties for cost team members as required. Seeks out continuous improvement best practice with an emphasis on what can be learned and implemented at Cook Ireland to drive a best in class operation and efficient processes. Ensures that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications: Professional Accounting qualification (ACA, ACCA, CIMA) desired. 10 years operations finance experience with strong working knowledge of financial and non-financial metrics, lean manufacturing practices, and product costing. Strong leadership skills with the ability to clearly communicate a vision, educate individuals and teams, and influence decisions. Previous experience managing a team. Excellent communication and interpersonal skills. Proven problem solving skills. Strong organisation skills. High level of self-motivation. Experience with Microsoft office products. Experience in SAP’s Business Objects preferred. Availability and willingness to travel on company business. #J-18808-Ljbffr
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 criterion development, stability testing, out of specification (OOS) investigation, post-approval manufacturing changes, verification of active pharmaceutical ingredient (API) components to recognized compendial standards and API vendor qualifications and audit. Reporting to: Manager, Post Market Engineering / Team Lead, Post Market Engineering Find out more about Cook Medical here. Responsibilities: Maintain high level of expertise in FDA, US Pharmacopeia and/or European Pharmacopeia and ICH guidelines related to CMC regulatory topics. Provide oversight in the development of CMC strategies to support global regulatory strategy and submissions. Support submissions pertinent to CMC for global regulators. Technically review data and reports for accuracy and consistency with regulator’s expectations (including, but not limited to stability data and lot release data such as HPLC, Particulate, Dissolution). Provide CMC expertise and collaborate with stakeholders to identify contract manufacturers, API vendor selection, qualification and support audits of same. Lead or participate in engineering projects serving as subject matter expert within the field of CMC and test method development. Provide input on new product introduction and assessing proposed manufacturing changes and provide guidance during implementation of product changes. Support the Investigation / Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations. Collaborate with other Post Market / Manufacturing Engineering Teams to ensure the effective completion of all activities associated with Post Market Engineering projects / objectives. Collaborate and interact effectively with other Cook companies and global functions within Cook (e.g., Regulatory Affairs, Engineering, Operations (Manufacturing), and Quality) to develop and implement CMC strategies. Ensure effective reporting to the Post Market Engineering management team. Work closely to build effective relationships with other functions in particular Production, Quality and Regulatory teams. Ensure that all activities are in compliance with Cook’s Code of Conduct, Cook’s Quality System requirements, and Company HR policies. Liaise with other Cook manufacturing facilities as required. Qualifications: Bachelor’s degree, Masters or PhD is required, preferably in engineering/science or a related field. Minimum of 3 years’ relevant experience with CMC. Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards. Familiarity with FDA, US Pharmacopeia and/or European Pharmacopeia and ICH CMC regulatory topics. Proven analytical and problem-solving skills. Strong interpersonal skills and the ability to communicate across functions. Familiarity with statistical methods, analysis, and interpretation. Ability to work on multiple projects, organize, and prioritize within time constraints. Familiarity with Microsoft Office software. High self-motivation. Willingness and availability to travel on company business. About Cook Limerick: Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralised customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets. Our employee benefits include: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #LI-Hybrid #J-18808-Ljbffr
Overview: The Manufacturing Engineering Specialist is responsible for the preventative maintenance schedule of equipment used in production and engineering. This also includes maintaining a database and all related documentation. Reporting to: Manager, Manufacturing Engineering Responsibilities: Maintain and implement the daily and weekly preventative maintenance (PM) schedule for all production equipment. Maintain the PM documentation and database according to company operating procedures and compliance with Cook Medical quality system. Carry out set-up manufacturing equipment within the production environment. Record and verify inputs. Ensure that preventative maintenance is carried out in a timely manner, which may include liaising with outside agencies, including the setup of such contracts. Work with equipment manager on the set-up of new equipment task plans / material lists. Support with the equipment installation process through Infor EAM. Resolving breakdowns in production areas and record in Infor EAM. Maintaining adequate stock levels of spare parts and ensure recording of same when used. Record hours spent on carrying out maintenance activities. Review maintenance schedules and tasks plans on an ongoing basis highlighting any areas for improvement. Deliver process improvements / continuous improvement activities as required. Ability and willingness to interact with various functions to problem solve and address equipment/maintenance issues. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Provide data, records and information to auditors when required. Qualifications: Minimum of 5 years’ experience in a production/technical support role is required. Production/Technical qualification is preferred. Good communication and inter-personal skills. Knowledge of medical device quality standards/practices or similar regulated industry would be an advantage. Willingness to seek out and drive improvement. Demonstrated problem solving skills. Highly motivated individual, self-starter with a passion for excellence. Good computer skills including knowledge of Microsoft Office. Proficient in CAD software CREO or similar programs is advantageous. Must be a good team player who is capable of working well to tight deadlines. High degree of self-motivation. Willingness and availability to travel on company business. About Cook Limerick: Cook Medical has been in Limerick since 1996, starting out with labeling and distribution and steadily growing and evolving to include manufacturing, centralized customer support and on to collaborative product development in the Innovation Centre. The Ireland location is our European headquarters and houses our EMEA Support Centre. This location currently employs more than 1000 people and manufactures 10% of Cook’s products for global markets. Employee Benefits: Hybrid Work Model Company sponsored Defined Contribution pension scheme Medical Health Insurance cover for you and your immediate family Life Assurance and Income Protection cover Educational Assistance Performance related Bonus Extensive health & wellness program including Indian head massages, healthy lifestyle seminars, mindfulness courses, physio sessions, flu vaccinations, nutrition talks Fully equipped gym on site 39-hour week with flexible start & finish times Paid time off to participate in volunteer activities Free parking Subsidised restaurant Sports & Social club #J-18808-Ljbffr
The primary function of this role is to ensure regulatory adherence of Cook Medical's document control process. Reporting to: Manager, Quality Systems Responsibilities: Change Analyst within the Agile Product Lifecycle Management (PLM) system. Processing and GMP / GDP review of Change Orders (CO’s). Ensure Change Orders are implemented fully. Maintenance, control and distribution of Quality System documentation. Obsolete and distribute Quality Management System documents. Maintenance and control of the Document log. Generation and distribution of data on the effectiveness of the Documentation system. Global Part Number (GPN) Assignment and CIMS update for non-Cook Ireland product. Bill of Material (BOM) updates. Supply Chain updates for non-Cook Ireland product. Global Product File (GPF) updates and maintenance of the GPF. IFU/PFI File Management updates. Implementation of Global Document Control processes and systems as appropriate. Management and maintenance of Quality Systems records. Participation in Internal Audits if desired. Support External Audits where required. Provide training on Quality System procedures where required. Ability to lead and drive assigned Process Improvements within the Document Control Department essential. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications: Cert/Diploma in Quality related discipline desirable. Excellent PC skills, particularly Microsoft Office. Previous experience of working in a Quality environment would be advantageous. A self-starter and motivated to learn all aspects of the role. Ability to work independently but also work well as part of a team. High attention to detail. Strong interpersonal skills with the ability to communicate effectively at all organisational levels. Project Management abilities highly desirable. Strong organizational skills. Ability to set priorities, develop a work schedule, monitor progress towards goals, and track details/data/information/activities. Willingness and availability to travel on company business. Qualified and experienced Quality Auditor desirable but not essential. #J-18808-Ljbffr
Overview: The Regulatory Affairs Specialist 2 ensures regulatory compliance to the EU MDR at the office of the EU Authorised representative (AR). The EU AR Office is responsible for verifying compliance to the EU MDR on behalf of Cook Medical’s non-EU manufacturers. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the EU regulatory authorities. Responsibilities: Maintain an excellent understanding of the medical device regulations of the EU, (EMEA (Including UK, Switzerland) and EN ISO13485). Ensure a thorough understanding of the products they are assigned to from the relevant Cook Manufacturer. Work with the global project manager EU MDR and other global and local team members to successfully implement the requirements of the EU MDR at the office of the EU Authorised Rep CMEU and/or sister Cook companies as required. Ensure processes and procedures are put in place and maintained as part of the QMS to carry out the role of EU AR as per Article 11 of EU MDR. Maintain close contact and links with relevant Cook manufacturing sites and ensure contracts/Mandates are in place between the EU AR and Cook manufacturers that the EU AR represents. Liaise with and respond to requests for information and/or documentation/samples from Competent Authorities. Inform relevant CA’s of any reportable incidents and field safety corrective actions. Complete the EU AR obligations as outlined under Article 11 and 12 of EU MDR. Complete the EU AR obligations under MDD and per agreements. Monitor post-market surveillance as necessary. Identify and monitor legislative and regulatory activities, update processes and procedures as appropriate and report their potential impact on the company to local and global leadership as necessary. Coordinate multiple projects at one time and provide regular reports to regulatory management and others as required. Serve as a liaison on regulatory issues between the Cook Manufacturer and the Office of EU Authorised Rep. Provide assistance to Cook UK (UKRP) and the Swiss Representative. Provide support to currently marketed products as necessary including input on change requests, PMS etc. Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations. Provide regulatory support to Cook functional units such as the SSC, tenders, CMEU acting as import/distributor, customer quality and distribution partners. Provide support for regulatory audits. Perform additional duties as assigned. Act as RA change analyst. Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf. Qualifications: Third level Qualification preferably in Science/Engineering or Law; 2-5 years’ experience in a regulated industry in a similar role desirable. Ideally have knowledge of requirements of European Medical Devices Regulation (EU-MDR), Regulation (EU) 2017/745, Medical device Directive (93/42/EEC). Knowledge of medical device quality standards/practices or similar regulated industry. Good communication and inter-personal skills. Proven problem-solving skills. Good computer skills including knowledge of Microsoft Office. Proven organizational skills. High self-motivation. Approved External Auditor. Willingness and availability to travel on company business. #J-18808-Ljbffr
