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
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: