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Kleboe Jardine Ltd

Regulatory Affairs Specialist

Fife
Posted about 16 hours ago
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Kleboe Jardine are supporting an established global medical technology company with the appointment of a Regulatory Affairs Specialist on a 12-month fixed-term contract.

This is a broad, hands-on Regulatory Affairs position with a particular focus on global product registrations and market access.

You'll take ownership of registrations across multiple international markets, working with distributors and internal teams to ensure products remain appropriately registered, upcoming renewals are managed and regulatory requirements are understood when products or markets change.

The Opportunity

It's a varied role where you'll be managing multiple regulatory activities at any one time, including:

  • Managing medical device registrations across global markets
  • Working with international distributors and third parties to support device clearance
  • Maintaining active registrations and proactively managing upcoming renewals and expiries
  • Assessing product changes and understanding their regulatory impact across different countries
  • Supporting change control, risk assessments and technical documentation
  • Advising project teams on regulatory requirements
  • Supporting market access into new countries and regions
  • Maintaining accurate registration information within regulatory systems

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What We're Looking For

We're looking for a well-rounded medical device Regulatory Affairs professional who can quickly understand different global requirements and confidently communicate what they mean for the wider business.

Experience in global registrations and market access would be particularly valuable, alongside knowledge of product change assessments, technical documentation and medical device regulatory requirements.

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You'll need to be organised and comfortable managing a busy portfolio – there can be around 50 product changes in progress at any one time, so being able to prioritise, keep track of different markets and work proactively is important.

Why Consider It?

This is a great opportunity if you enjoy the variety of Regulatory Affairs rather than specialising in one narrow area.

You'll gain exposure to numerous international markets, work across an established medical device portfolio and have genuine ownership of global registration and market-access activities.

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Location

Fife, Scotland, United Kingdom

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