Regulatory Affairs Officer Role

Dublin South  ‐ Onsite
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Description

A medical device company in South Dublin are currently recruiting a Regulatory Affairs Specialist. Since the company's formation over 20 years ago, they have strived and succeeded in becoming one of the leaders in the Diagnostic Industry. This is a great opportunity to join a company that prides themselves on attaining excellence in their field with hundreds of products in their portfolio.

As the Regulatory Affairs Specialist, you will be responsible for ensuring continuous compliance with regulatory standards for the companies Irish products. Responsibilities will include:
- Provide regulatory advice & support to the company business units.
- Liaise with all Professional & Regulatory bodies in the industry as appropriate on regulatory or legislative changes which impact on the company and to ensure effective implementation within the company.
- Manage and co-ordinate all company vigilance/recalls activities.
- Provide guidance on worldwide regulatory requirements, providing regulatory strategies and co-coordinating during transfers, registrations.
- Work as part of project teams in support of product registrations and liaison with customers and regulatory bodies during this process.
- Create and maintain Product technical Files according to the IVD Directive 98/79/EC.
- Act as Regulatory Affairs representative on the Design Control/Change Committee.
- Responsible for maintaining awareness of the changing regulatory requirements.
- Represent Regulatory Affairs at regulatory and customer audits.

Required Skills:
- Good knowledge of Regulatory Directives, Regulations and Standards.
- Good working knowledge of Microsoft Excel, Word and Powerpoint.

Minimum Requirements:
- BSc in a Science Subject
- Minimum 2 years experience previously working in a Regulatory Affairs role in Pharmaceutical or Medical Devices.

This is a permanent position with a salary of €40000 - €45000 on offer.

If you feel you would be a good fit for this role call me, Niamh Irwin, on for immediate consideration or apply directly to this advert.
Start date
03/2014
From
Real Staffing
Published at
12.03.2014
Project ID:
677627
Contract type
Permanent
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