On behalf of my client, a medical devices company based in Dublin, we are recruiting for the role of Regulatory Affairs Manager. Fantastic opportunity for someone to bring their skills to this company. In return you get autonomy, flexibility and the option to work remotely.
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:
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.