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Requisition ID 2022-12035
Requisition Post Information* : Posted Date 1 month ago(21-12-2022 6:37 AM)
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
Work Status
Hybrid
Company
Cook Ireland
Job Location
Limerick Ireland
Multiple Locations
No
Language Requirement
English
Requisition ID 2022-11913
Requisition Post Information* : Posted Date 1 month ago(21-12-2022 11:16 AM)
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
Work Status
Hybrid
Company
Cook Ireland
Job Location
Limerick Ireland
Multiple Locations
No

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Cook Medical is proud to be an equal opportunity employer and we know that diversity makes us stronger and better as a company. Every day we make life-saving products and do what is best for patients worldwide, and the people that join Cook make this possible. In keeping with our Cook Group values, we are committed to treating all employees equally regardless of gender, civil status, family status, sexual orientation, religious belief, age, disability, race or membership of the traveller community. It is our policy to ensure that as much accommodation as possible is carried out to facilitate the participation of all individuals to ensure equity in the recruitment process and in the workplace.