Regulatory Affairs Executive - Dublin

Dublin  ‐ Onsite
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Description

Are you looking for a challenge at a global Medical Device company where you can thrive in a strong culture of continuous exchange?My Client currently requires a talented, motivated, experienced and enthusiastic individual to join their Regulatory Affairs Division.

The Regulatory Affairs Executive will report to the Regulatory Affairs Manager.
Management of product complaints for products on the Irish Market, from initial receipt through to closure, in conjunction with the company's Global Complaints Department and in accordance with all relevant IMB Guidelines, Regulations and Standard Operating Procedures.

Responsibilities:
-Liaise with customers, in collaboration with the Sales/Marketing teams, regarding product quality
-Provide annual training to all relevant personnel on the handling of complaints.
-Support Pharmocovigilance, Medicovigilance and Compliance activities as directed when required.
-Ensure all medicinal product registrations are current and marketed in full compliance with their approved registrations files.
-Preparation, submission and follow-up of medicinal product applications, as required and directed to the IMB and associated liaison with Global Regulatory Affairs.
Requirements:
-Degree in a life science or pharmacy discipline.
-2 years work experience in a compliance environment and a good understanding and working knowledge of GxP.
-Knowledge of EU and national regulatory requirements.
-Ability to process technical information.

If you are interested in this great opportunity to gain a wealth of experience in a family orientated work environment and have the relevant skills and experience please contact me Anna Mooney or apply below with an up to date CV.

To find out more about Real please visit www.realstaffing.com
Start date
07/2013
From
Real Staffing
Published at
20.07.2013
Project ID:
570199
Contract type
Permanent
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