Senior Regulatory Affairs Associate - Remote, United Kingdom - Terumo

Terumo

Verified Company

Remote, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Permanent

Senior Regulatory Affairs Associate

Remote Based

_Terumo Aortic are looking for a Senior 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._
**_Key Duties:
- _*

Assist in the production and review of design dossiers technical files, and Product Approval Certificates.
Preparation of regulatory submission for product approvals.
Preparation of Custom Made device, Special Products paperwork and change assessments.
Participate in Design Control, Risk Management, Post Market Surveillance and document changes.
Facilitate compliance with Vigilance System.
Update and review all IFU, Packaging and Labelling
Other duties as required by Regulatory Affairs department

**_Qualifications & Experience:
- _*

BSc Hons Degree or equivalent.
Regulatory experience within a medical device or pharmaceutical environment is desirable.
Class 3 Medical device experience preferred

This role can be remote based with occasional travel to our Glasgow site.