Our client, a growing medical device organisation based in Galway, is seeking an experienced Senior Regulatory Affairs Specialist. This role will be responsible for all regulatory activities including product certification and compliance, and for supporting the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System.

The Role

This is a contract role that is remote based to support on a specific project, providing expert knowledge of regulatory processes for EU, UK and FDA product clearance.

Key Responsibilities would include:

• Prepare regulatory submissions for required markets coordinating input from other stakeholders, tracking and supporting product clearances and certification to completion.
• Maintain technical files for all cleared products.
• Complaints handling for medical reporting and filing to the appropriate competent authorities.
• Maintain environmental registrations for all target markets.
• Complete internal audits as required and lead CE technical file audits for the company.
• Support the Quality team in maintaining the QMS.

The Person

In order to be considered for this exciting daily rate Senior Regulatory Affairs Specialist role, specific requirements for the successful candidate would include:

• Degree (L8) qualified in engineering, science, or a technical equivalent.
• Minimum of 5+ years relevant within the medical device sector in a relevant role.
• Significant regulatory affairs experience including experience of international regulatory processes.
• In depth knowledge of product certification testing requirements for active Medical Devices.
• In depth knowledge of maintaining a certified Quality Management System.

What's on offer:

• Exciting daily rate contract role within a growing medical device company.
• Opportunity to work within a technical team giving you access to build your portfolio within the medical device industry.

To discover more about this opportunity, apply now or contact Laura Gallagher at HRM on +353 91 782 113 for a confidential discussion.