Regulatory Affairs Executive

Description

My Galway based client, is in need of a Regulatory Affairs Executive to Join their RA team for
an exciting 6 month contract. Working alongside the RA manager, this is an opportunitunity to broaden your hands on Regulatory experience in a start up Medical device company for a 6 month contract.

Role responsibilities:

*To assist the Regulatory Manager in preparing and reviewing submission packages to the IMB and MHRA in a timely manner.
*Write and prepare responses to a high quality
*To raise and action appropriate change control and maintaining compliance
*To prepare and submit high quality submission for post approval activity to strict dead lines
*Liaise with the Regulatory Authorities to ensure product approvals are received in a timely manner
*Review artwork for national phase submission and prior to launch
*Review health authority website for product safety updates and new requirements
Candidate requirements:

*MSc or BSc degree in a scientific discipline
*Must have high attention to detail and proactive
*Ability to prepare high quality regulatory applications
*Demonstrate good communication skills
*Demonstrate excellent verbal and written English
*Ability to handle multiple tasks in a fast-paced and constantly changing environment
*Good knowledge of Microsoft word and Excel
*Knowledge of drug development is desirable although not essential
*Knowledge of Decentralised procedures is desirable although not essential
*Eligible to live/work in the Ireland

If this role sounds like an ideal match for your skillset and career aspirations please contact me Anna Mooney or click below and apply with an up to date CV.

To find out more about Real please visit www.realstaffing.com