As a Regulatory Affairs Manager, you will be responsible for all Quality and Regulatory issues within the company. You will oversee the ongoing management of an ISO 13485 quality management system, as well as preparing and co-ordinating regulatory submissions for products outside the EU.
We are looking for a qualified candidate that has worked in Regulatory Affairs with significant working knowledge of ISO 13485 and project management or product development experience.
Reporting to the CEO, you will manage the representative for external audit whilst performing internal and external audits. Great opportunity to join a successful and established company offering a stimulating work environment and training.
To be considered for this superb position, you must have:
- A third level qualification in a science or engineering discipline (minimum NFQ level 8)
- At least five years’ experience in a similar role with a working knowledge of ISO 13485
- Project management or product development experience
- Knowledge of FDA regulations and/or submissions and familiarity with electronic submissions
- Proficiency in MS Office and document management systems
Additionally, as a Regulatory Affairs Manager, you must possess first class communication and interpersonal skills, both verbal and written, coupled with a strong multi-tasking ability. You also must have an analytical nature and plenty of business acumen.
For full details contact Tina email@example.com or call +353 1 2784701 or 087 6811990
Thornshaw Scientific is a division of the CPL Group. www.thornshaw.com