Senior Regulatory Affairs Associate

2 weeks ago

United Kingdom Terumo Aortic Full time

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 productionand 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.

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