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 globally and revenues north of 16 billion per annum, this organisation remains one of the largest global 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. One of the organisations' primary plants based in Leinster is currently undergoing significant investment and change. It has transformed its operations in Ireland through strong leadership, continuous innovation and demonstrating the importance of this site to the organisations global manufacturing operations. At present, a requirement exists for a Regulatory Affairs Specialist to join it's expanding operation in Wexford.
As RA Specialist, you will report directly to the RA Manager and your responsibilities will include;
- Participate in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory submissions plan around product development/line extension goals.
- Prepare U.S. FDA submissions (e.g., 510(k) US Submission for Medical Device Class 2 Device, IDE Requesting to do a clinical trial) as required and per applicable SOPs.
- Prepare and updates European and international technical files/dossiers/registrations as required and per applicable SOPs.
- Review Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards.
The ideal candidate will have a third level Science OR Business qualification.
- Will have RA related experience.
- Will have knowledge of U.S. and/or European regulations and standards covering medical devices.
- Will be IT literate and adapt to new systems easily.
- Will have excellent written and oral communication skills coupled with your willingness to learn, help other team members, collaborate and support where needed.
- Will have attention to detail, be adaptable and embrace change.
To learn more about this role apply online or call Helena Boyle on + 353 1 6321870 or 0873360953 for a confidential discussion.