Senior Regulatory Affairs Specialist with experience working in Regulatory Affairs within the medical devices sector required for permanent role with medical devices multinational in Co. Offaly. In this role you will be responsible for the development and implementation of global regulatory strategies based on European Medical Device Directive & US FDA regulations for Class II medical devices.
- Bachelor’s Degree in Science / Engineering
- 3-5 years of experience working in Regulatory Affairs within the medical devices sector
- Proven skills in the developing CE registrations and US PMA/510(k)
- Possess knowledge of US FDA regulations, ISO Standards, and European Medical Device Directive (MDD)
- Experience working with US FDA, European Notified Bodies and Competent Authorities and other regulatory agencies
Please contact Emer Moore to discuss in confidence