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Randstad Logo Randstad · -

Senior Regulatory Affairs Specialist (EMEA)

United Kingdom, Warrington 50.00 - 60.00 GBP / Hour · Job Posted April 16, 2026

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Job Description

We are seeking a high-energy Senior Regulatory Affairs Specialist to provide leadership and strategic support for IVD/MD (In Vitro Diagnostic and Medical Device) registrations across the EMEA region. Reporting to the Director of Regulatory Affairs EMEA, you will work within a dynamic, international environment to ensure market growth and revenue protection through strict regulatory compliance. This is a versatile role that can be performed remotely or as a hybrid arrangement out of our Warrington site, with occasional business travel (approx. 10-15%) for escalations and site visits.

Job Responsibility

  • Lead national product and establishment registrations across EMEA markets, ensuring all timelines are met
  • Develop and execute regional registration strategies that align with global commercial objectives
  • Maintain professional relationships with regulatory authorities and third-party distributors to facilitate smooth submission processes
  • Monitor and interpret evolving EMEA regulations, providing impact assessments and guidance to legal manufacturers
  • Maintain and update regulatory databases and activity trackers to ensure full traceability of technical documentation
  • Use Practical Process Improvement (PPI) tools to streamline request management and train internal stakeholders

Requirements

  • 8-10 years of Regulatory Affairs experience specifically within the IVD or Medical Device sectors in the EMEA region
  • Deep expertise in ISO13485 Quality Systems, as well as European IVD and MD regulations
  • Proven track record of successful registrations across Europe, the Middle East, and Africa
  • Ability to understand and communicate complex scientific principles related to reagent chemistry, laboratory automation, and software components
  • A proactive, "hands-on" leader who is comfortable with ambiguity and thrives in a matrix-managed organisation
  • Excellent oral and written English skills, with the ability to collaborate effectively across different time zones (US, Europe, and Asia)

What we offer

A laptop and necessary accessories will be provided for this role

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