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Regulatory Affairs Officer

Location: Sligo, Republic of Ireland Salary:
Sector: Regulatory Affairs (RA) Type: Contract


Role: Regulatory Affairs Officer
Location: Sligo
Contract Length: Initial 6 month contract

As a Regulatory Affairs Officer, you will be responsible for the submission of technical files & design dossiers, and report to the QS/QC Manager. As Regulatory Affairs Officer you will serve as an intermediate between the manufacturer & local regulatory authorities.

Responsibilities:
* Submit Technical & Design Dossier files
* Liaise with/Respond to Regulatory Authorities
* Plan & prepare regulatory submissions
* Organise & maintain regulatory data
* Ensure product approval & compliance in accordance with ISO13485,MDD93/42/EEC & FDA QSR 21 CFR Part 820
* Compile regulatory information for management review

Requirements:

* 1-2 years of Medical device/ Pharmaceutical background
* B.Sc. in Science or an equivalent qualification
* Good communication skills
* Good technical skills
* Problem solving skills

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

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales