Career opportunities

The primary role of the Regulatory Affairs Project Manager is to provide support for the daily activities associated with global regulatory projects, including communicating with the various teams on regulatory projects. 

The regulatory affairs associate assists in the implementation of regulatory strategies, performs activities associated with the EU Authorised representative office. The regulatory affairs associate serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities. Reporting to: CMEU Regulatory Affairs Manager Find out more about Cook Medical here

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: CMEU Regulatory Affairs Manager     Find out more about Cook Medical here

The Regulatory Affairs Administrative Assistant carries out the Administration duties for the Regulatory Affairs group. These duties include updating Regulatory Affairs databases and logs as necessary, preparing and updating regulatory affairs documents and other administration functions as assigned.   Reporting to: Regulatory Affairs Manager       Find out more about Cook Medical here

The Regulatory Communications Specialist 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), field action and associated correspondence to applicable Regulatory bodies.        Reporting to:Regulatory Communications Team Lead        Find out more about Cook Medical here