Career opportunities

Senior Regulatory Affairs Specialist – Post Market Surveillance & Clinical will be involved in the review and approval of post market surveillance (PMS) plans and reports for Cook Ireland medical devices. In addition, the Senior 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          

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   

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     Find out more about Cook Medical here

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     Find out more about Cook Medical here