Careers in Regulatory Affairs at Cook
Cook is truly patient focused in the work we do. We have always prioritised patient safety while providing innovative products and solutions. Our Regulatory Affairs teams are central to holding Cook to the highest standards because everything we do has an impact on someone’s life.
We have Regulatory Affairs teams in Ireland, Denmark, the US, Australia, and Asia and are currently recruiting for roles in our Limerick, Ireland, site. The two Regulatory Affairs teams at Cook Medical’s site in Limerick, Ireland, are an experienced group of professionals who drive regulatory excellence through cross-functional collaboration and continuous improvement. This enables them to present Cook Medical devices to regulators globally, to obtain and maintain market authorisations and continuously monitor their safety and performance.
One team is based at the manufacturing site and are responsible for regulations in over 60 countries for both of Cook’s clinical divisions. The second team is established at the EU Authorised Representative office who represent all Cook Medical devices to regulators in Europe. They ensure a focused and consistent approach to the EU Medical Device Regulations (EU MDR) across Cook Medical.
What’s involved in our Regulatory work
Cook is a well-established company with experience in regulatory submissions across the globe, including:
- Europe
- Medical Device Single Audit Program (MDSAP) countries (Australia, Brazil, Canada, Japan, and the United States)
- Asia-Pacific (China, South Korea, India, Singapore, and other jurisdictions)
- Latin America
- The Middle East
Our Regulatory department manages both pre-market and post-market regulatory responsibilities for both existing and novel devices across a wide product portfolio from both of our clinical divisions, across all classifications. Our Regulatory Affairs teams work closely with other departments, including quality and engineering, during the device design process and throughout the device lifecycle. They are involved in a broad range of activities, including:
- Regulatory strategy
- Regulatory intelligence
- Global market authorisations
- License renewals
- Design and development reviews
- Post-market surveillance
- Clinical evaluation and post-market clinical followup
- Regulatory reporting and field action
They are also the point of contact for Cook Medical sister companies, international regulatory authorities, competent authorities, and notified bodies.
Available roles
The opportunities available within our Limerick teams range from entry level right up to global leadership. Training is provided and team development and progression are encouraged and fostered.
View our current Regulatory vacancies and send in your CV today if you feel you would be a good fit with our teams.
Roles within our Regulatory Affairs team
(Not all have vacancies at this time)
Associate
- Entry-level role
- Third-level qualification in science or engineering desirable, but no regulatory experience required
- Regulatory Affairs training and mentoring provided
Specialist
- Third-level qualification in science or engineering
- 2 to 5 years’ experience in a similar role or regulated industry is desirable
Senior
- Third-level qualification in science or engineering
- 5 years’ experience in a similar role or regulated industry is desirable
- Includes people management responsibilities
Manager
- Third-level qualification in science or engineering
- 5+ years’ experience in a similar role or regulated industry is desirable
- Supervising the day-to-day workload and operational issues of a Regulatory Affairs team
- Review and approval of documentation