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Regulatory Affairs Graduate

Reference:AFSQ-170870
Location: Westmeath
Qualification:Degree
Experience:Graduate
Job Type:Fixed Term Contract
Salary:Not Disclosed
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May be suitable for: Graduate

Regulatory Affairs Graduate
Position will report the Regulatory Affairs Manager. This is a 1 year contract role. Position supports and regulates activities which lead to and maintain compliance.

Responsible

• Assigning and logging of Registration requests for EMEA region
• Preparation of information to support Product Tender Applications and queries in the international markets
• Maintenance of product registration database
• Reconciliation of files and maintenance of files
• Support other activities as required
• Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives
• Support Regulatory inspections at the site as directed
• Liaise with other departments to ensure correct supporting data generated and provided in a timely manner
• Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives

Requirements

• Excellent analytical ability
• Excellent technical writing experience within a medical device environment
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously
• Ability to interface with all levels of management
• Travel up to 30%
• Engineering/Science Degree
• Fluent English, both written and oral
• Problem solving skills for developing creative solutions and meeting objectives are required
• Attention to detail and accuracy
• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)


If you would like further Information you can contact the recruiter directly:

James Cassidy | Tel: +353 (0) 1 5079250




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