Career opportunities

The primary function of this role is to lead a team of the regulatory communication specialists that serve 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. Agree objectives, generate training plans, coach team members, carry out performance appraisals and deal with performance related issues. Assess workload for the group and allocate tasks accordingly.   Reporting to: Quality Engineering Manager       Find out more about Cook Medical here

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