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Regulatory Affairs Associate

3 months ago

Edinburgh, Edinburgh, United Kingdom Entrust Resource Solutions Full time

Regulatory Affairs Associate

IVD

Edinburgh

I am very pleased to be able to offer this role with one of our established clients, responsible for manufacturing various successful IVD products. With a global presence and several large sites, this is a great opportunity to take your regulatory experience global and work within the UK, EU, APAC and US markets

Main Responsibilities: -

  • Compile and assist with global regulatory submissions including 510(k) submissions
  • Complete product labelling tasks
  • Liaise with external and internal stakeholders including competent authorities
  • Conduct process improvements projects within the team

Key Requirements: -

  • Experience within IVD Regulatory Affairs is essential
  • A communicative personality is beneficial
  • Experience in global markets is also beneficial

Why Apply?

  • No doubt the diagnostics world has been shaken after the COVID-19 situation, but on offer is a stable position, with a business who have been operating for 17 years. They now have over 300 employees across multiple sites and a successful product portfolio.
  • A flexible working model
  • What the team describe as a positive, supportive culture with on-site facilities, regular social incentives if you want to partake, and health and wellbeing initiatives.

Apply now by hitting 'easy apply' or emailing