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