Regulatory Affairs Associate
Competitive + Bonus + Benefits

Regulatory Affairs Associate

Ref: 13| Posted: 12th Sep 2023

Terumo Aortic are looking for a Regulatory Affairs Associate to join our team on a fixed term contract 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.