The primary function is to assist in the manufacturing & shipment of medical device products.

Reporting to: Production Supervisor  

Find out more about Cook Medical here

• Carry out any process steps required for the manufacture & shipment of high quality medical devices products.
• Adherence to COOK Quality system procedures and all associated manufacturing documentation which is provided to employees in order to assist them in the manufacture & shipment of high quality products.
• Responsible for the completion of training in relation to the manufacture & shipment of product.
• Ensure that a high standard of GMP and housekeeping is maintained in all manufacturing areas.
• Adherence to all Environmental, Health and Safety requirements in accordance with company Policies.
• Highlight any potential issues to team leaders/Supervisors.
• Provide flexibility in working on any other tasks that may arise during the course of a normal day in a production environment.
• May perform other duties as assigned by Supervisor.
• Working as part of a team within the Production area.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

• Experience in a production environment preferred.
• Previous experience in medical devices, while not essential is advantageous.
• Good communication and inter-personal skills.
• Ability to work as part of a team.
• Some flexibility as regards working hours/days.
• Willingness and availability to travel on company business

Overview

The primary function is to assist in the manufacturing & shipment of medical device products.

Reporting to: Production Supervisor  

Find out more about Cook Medical here

Responsibilities

• Carry out any process steps required for the manufacture & shipment of high quality medical devices products.
• Adherence to COOK Quality system procedures and all associated manufacturing documentation which is provided to employees in order to assist them in the manufacture & shipment of high quality products.
• Responsible for the completion of training in relation to the manufacture & shipment of product.
• Ensure that a high standard of GMP and housekeeping is maintained in all manufacturing areas.
• Adherence to all Environmental, Health and Safety requirements in accordance with company Policies.
• Highlight any potential issues to team leaders/Supervisors.
• Provide flexibility in working on any other tasks that may arise during the course of a normal day in a production environment.
• May perform other duties as assigned by Supervisor.
• Working as part of a team within the Production area.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

• Experience in a production environment preferred.
• Previous experience in medical devices, while not essential is advantageous.
• Good communication and inter-personal skills.
• Ability to work as part of a team.
• Some flexibility as regards working hours/days.
• Willingness and availability to travel on company business

Overview

The Regulatory Affairs Specialist - Regulatory Communications serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities and assists in assessing complaints for Regulatory Reporting, this includes Adverse Event Reporting (MDR, Vigilance, etc.), Post Market Surveillance Activities (PMS, PMCF, CER) and associated correspondence to applicable Regulatory bodies.

 Reporting to:               Senior Regulatory Affairs Specialist   

Find out more about Cook Medical here

Responsibilities

• Assess complaints from Cook global distribution centres for adequate information to determine if event meets Regulatory Reporting requirements.
• Utilize appropriate complaint software systems for processing complaints to/from distribution centres and QE Investigation functions.
• Generate appropriate regulatory reports based on assessment.
• Liaise effectively with regulators on all issues with regard to regulatory reporting.
• Ensuring that confirmed reportable events are escalated to the appropriate personnel in a timely manner.
• Communicate with other Cook Companies globally as necessary for reporting.
• Generate responses to inquiries on AE reports from various global regulatory authorities.
• Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests.
• Assist in coordination of Recall / Field Action administration activities between manufacturer and distribution centre.
• Reviewing and approving reports and responses as necessary.
• Close out of complaints as necessary.
• Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports, Post Market Clinical Follow Up (PMCF) plans and reports and clinical evaluations (CEPs, CERs). Maintains appropriate regulatory records to demonstrate compliance with applicable regulations.
• Liase and advise other Cook functional units (Engineering, Divisions, Quality etc) of the relevant requirements for PMS and PMCF and ensures the outputs from the individual functional units meet the applicable regulatory requirements. Review and analysis of data for same.
• Maintain an excellent understanding of global medical device regulations.
• Responsibility for implementing applicable regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required.
• Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
• Serves as a liaison on regulatory issues between the Cook Manufacturer and the Cook International local office and/or Cook distribution partner.
• Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
• Performs additional duties as assigned.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

• Third level Qualification in Science/Engineering desired.
• A number of years experience in a regulated industry in a similar role required.
• Thorough knowledge of the EU & US medical device regulatory requirements.
• Knowledge of regulatory requirements in MDSAP countries.
• Desirable to have knowledge of requirements in other jurisdictions.
• 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.

About Cook Medical

Since 1963, Cook Medical has been finding solutions to improve the world’s healthcare problems for the patients and doctors we serve. As one of the world’s largest private companies, we have always operated with our patients, customers, employees and communities at our core. We do this, not only because it is good business, but also because we believe that being a good corporate citizen is the right thing to do.

Cook Medical has been in Limerick since 1993. Since opening, we have become a European headquarters for many of Cook’s business functions.

With a global workforce of 12,000, we employ over 850 people in Ireland who bring Endoscopy, Urology and Peripheral Intervention products from conception to commercialisation.

Regulatory in Limerick

Our RA team in Limerick are responsible for global regulation in over 60 countries, managing pre- & post- market regulation for all product classifications and novel devices across EMEA, AMER and APAC.

Working cross functionally with clinical, quality and engineering during the design process and throughout the device lifecycle, RA are involved in a broad range of activities including marketing authorization and submissions, vigilance and adverse event reporting and clinical evaluation. Our Regulatory Affairs team are central to holding Cook to the highest standards because everything we do has an impact on someone’s life.

Our employee benefits include:

• Life Assurance and Income Protection cover
• Educational Assistance
• Company sponsored Defined Contribution pension scheme
• Medical Health Insurance cover for you and your immediate family
• 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

Overview

The primary purpose of this position is to provide technical support to operations in the following areas:

• Assist Engineers to develop production processes and ongoing process improvements.
• Ensure the efficient transfer of prototype and pilot products to full production status and support these product lines on an on-going basis.
• Preparation of change control documentation in order to ensure timely processing of sister company change requests.
• Develop component and product drawings required by sister Company change requests.
• Assist in product development activity as required by Supervisor.
• Provide technical support for manufacturing processes as required by Supervisor.

Reporting to: Senior Manufacturing Engineer/ Manufacturing Engineer  

Find out more about Cook Medical here

Responsibilities

• Assist engineers to develop production processes and ongoing process improvements.
• Ensure the efficient transfer of prototype and pilot products to full production status and support these product lines on an on-going basis.
• Provide technical support for manufacturing processes as required.
• Ensure that work instructions, QSI’s etc are prepared as per Cook’s Quality System.
• Ensure that sister company Change Requests are processed and approved in a timely manner.
• Develop component and product drawings required by sister Company change requests.
• Complete Supplier Change Notifications as required and support Material Review Board process.
• Provide Technical input and support for the investigation and resolution of Non Conformances associated with processes by completing NC assessments and investigations.
• Ensure that all work is carried out according to Company procedures, and that a high level of productivity and quality is achieved and maintained.
• Responsible for the setup and support of production equipment.
• Work closely with the Machine Shop to develop jigs, fixtures and tooling to improve production efficiencies.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

• Formal Production/Engineering/Science qualification preferably and/or relevant manufacturing experience (medical devices, plastics, etc.)
• Good communication and inter-personal skills.
• Knowledge of medical device quality standards/practises or similar regulated industry would be an advantage.
• Good computer skills including knowledge of Microsoft® Office.
• Proficient in CAD software CREO or similar programs.
• Must be a good team player who is capable of working well to tight deadlines.
• High degree of self-motivation.

The primary role of the Senior Regulatory Affairs Specialist 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 affairs input for the functional areas.

Function will involve a thorough understanding of the regulatory requirements required for the Medical Device Industry.

Reporting to:               Regulatory Affairs Manager

• Assists in the running of the Cook Ireland regulatory affairs programmes in accordance with internal procedures and regulatory requirements.
• Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required and other jurisdictions as required.
• Maintains an excellent understanding of the global medical device regulations.
• Maintains a thorough understanding of the 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.
• Highlights any updates to regulatory requirements to regulatory management.
• Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
• Reviews submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
• Develops global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
• 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.
• Ensures the biocompatibility requirements of the product are adequately addressed.
• Ensures the clinical requirements of the product are adequately addressed.
• 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 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.
• Maintains a system for registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
• Provides support to currently marketed products as necessary including input on change requests, etc.
• 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.

• Third level Qualification preferably in Science/Quality, 5 years’ experience in a regulated industry in a similar role is desirable.
• Ideally have knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required.
• 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.
• Approved External Auditor.
• Willingness and availability to travel on company business.