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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.
The Regulatory Affairs Project Officer carries out the Administration and Project Management duties for the Regulatory Affairs group. These duties include updating regulatory affairs databases and logs as necessary, preparing and updating regulatory affairs documents and tracking and managing projects.
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.
The Regulatory Affairs Specialist 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 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities.
Reporting to: Regulatory Affairs Manager
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.
The role of the Senior Specialist, Regulatory Affairs is to assist in the running of the Regulatory Affairs (RA) function. The Senior provides technical input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. Provides regulatory affairs support for the functional areas and input into regulatory strategies on behalf of Cook Medical.
Reporting to: Regulatory Affairs Manager
Find out more about Cook Medical here
The Senior Regulatory Affairs Communications Specialist – Post Market (Adverse Event Reporting & Field Actions) supervises and manages a team of RA specialists with responsibility for the Adverse Event Reporting and Field Action for all Cook Ireland devices.
Reporting to: Regulatory Affairs Manager
Find out more about Cook Medical here
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.
The primary role of the Senior Regulatory Affairs Specialist is lead a team & manage projects, 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.
Reporting to: Regulatory Affairs Manager
Find out more about Cook Medical here
Requisition ID
2019-6217
Job Location
Limerick Ireland
Multiple Locations
No
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