This leading medical device organisation has been a long-time investor here in Ireland with operations in Ireland since the 1960's. Employing in the region of 70,000 employees and revenues north of 16 billion per annum, they remain one of the largest medical devices organisations globally. Since its introduction to Ireland, this innovator has proceeded to continuously invest in this country including investments in additional manufacturing and research sites across Ireland. At present, a requirement exists for a Regulatory Affairs Specialist to join it's expanding operation in Limerick.
As a Regulatory Affairs Specialist, you will be working with the organisations latest technologies across a broad portfolio of products which includes Programmable Electrical Medical Devices and stand-alone software as medical device.
In addition, responsibilities will include:
- Compile and communicate regulatory requirements (e.g. MDD / MDR, standards, etc) to cross-functional groups in a concise and precise manner.
- Prepare and present gap analysis assessments of regulations and guidance's to peers and cross-functional groups.
- Review and approve the project documentation (design reports, labelling, etc.).
- Develop tactics supporting first to market commercial opportunities and minimise time to product launch.
- Input to the development of regulatory strategies and provide guidance and expertise.
You will have a minimum of 3 years' experience in a similar role. A third level qualification is required.
To discover more about this opportunity, apply now or contact Paul Wheatley at HRM on +353 87 344 9559 for a confidential discussion.