Regulatory Affairs Associate

Regulatory Affairs Associate II

Ref: 256| Posted: 9th Jul 2024

Terumo Aortic are looking for a Regulatory Affairs Associate II 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.

The key responsibilities include;

  • 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
  • Regulatory experience within a medical device environment