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.