Regulatory Affairs Advisor

Overview

Terumo Aortic are looking for a Regulatory Affairs Associate to join our team during an exciting time of growth and expansion for the business. This is a fantastic opportunity for someone to join our Regulatory Affairs team in a rewarding role with a company that offers career development amongst a host of excellent benefits.

Responsibilities

• Support regulatory projects as required
• Support writing technical/submission documents for Custom devices, CE devices and international registrations as required
• Support CAPAs and SATs from initiation to closure as required
• Review and maintain product approval certification database as required
• Prepare regulatory submissions for product approvals as required
• Prepare Custom Made device, Special Products paperwork and change impact assessments as required
• Other duties as required by Regulatory Affairs department

The successful candidate will possess

• Experience within medical device industry
• Some regulatory or quality experience within a medical device or pharma environment