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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 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
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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
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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 role of the Senior Regulatory Affairs Specialist is to assist in the running of the Regulatory Affairs (RA) function. The specialist will perform activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets, provide regulatory affairs support for other functional areas and input into regulatory strategies on behalf of Cook Medical.
Reporting to: Regulatory Affairs Manager
Find out more about Cook Medical here
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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
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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 primary function of this role is to supervise the Regulatory Affairs area to ensure that it runs in a smooth and efficient manner. Function will involve a thorough understanding of both the regulatory requirements required for the Medical Device Industry.
Reporting to: Director of Regulatory Affairs
Find out more about Cook Medical here
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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
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The Regulatory Affairs Specialist – Post Market Surveillance & Clinical will be involved in the development and generation of post market surveillance (PMS) plans and reports for Cook Ireland medical devices. In addition, the Regulatory Affairs Specialist will perform activities associated with PMS, including Post Market Clinical Follow-Up (PMCF), and Clinical Evaluation Plans and Reports (CEPs, CERs).
Reporting to: Regulatory Affairs Manager
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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 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
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The Regulatory Affairs Specialist 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 serves as a communication liaison between the Cook manufacturer and the EU regulatory authorities.
Reporting to: Director Regulatory Affairs, CMEU
Find out more about Cook Medical here
