Job Description

Position Summary

The Regulatory Affairs Co Op is responsible for determining and supporting the regulatory activies which lead to, and maintain regulatory compliance and approval for Teleflex Medical products globally

Principal Responsibilities

• Assigning and logging of registration requests for EMEA region
• Preparation of information to support Product Tendor Applications and queries in the international markets.
• Maintenance of product registration database
• Reconciliation of files
• Maintenance of files
• Support other activities as required
• Ensure all operations are fully compliant with licence details and updated in accordance with relevant guidelines and directives
• Supoport 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 licence details and updated in accordance with relevant guidelines and directives

Education / Experience Requirements

• Completed or undergoing Engineering/ Science qualification
• Excellent tecvhnical writing experience within a medical device enviroment - essential
• Attention to detail and accuracy
• Fluent English - both written and oral
• Work well under pressure and deadlines
• Excellent analytical ability

Specialized Skills / Other Requirements

• Problem solving skills for developing creative solutions and meeting objectives are required.
• Skills that enable coordination of data, including MS Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.

Behaviours / Values

• Approachable and enthusiastic.
• Flexible and adaptable
• Good organisational skills with cultural awareness and sensitivity
• Able to work on own initiative and as a team player
• Good judgement and problem solving ability