Regulatory Specialist

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Job Description

Regulatory Specialist

Pontypridd

£32,000 - £42,000

1 day WFH per week


Are you a Regulatory Affairs professional with experience supporting regulated products across global markets?

We’re looking for a Regulatory Specialist to take ownership of product Technical Files and support regulatory activities across multiple international markets.


What you’ll be doing

  • Owning and maintaining product Technical Files across key global registration jurisdictions
  • Creating key regulatory documents including Risk Management files, GSPR, Device Descriptions, and labelling
  • Organising and supplying documentation for NPD and EU MDR submissions / global registrations
  • Supporting the resolution of regulatory-owned quality plans and economic operator agreements
  • Identifying applicable standards and external test requirements and proposing options to the Regulatory Manager
  • Leading on label creation and templates, resolving operational labelling queries, and contributing to multi-site labelling projects
  • Liaising cross-functionally to support Regulatory activities
  • Maintaining regulatory logs and supporting internal/external documentation requests
  • Monitoring regulatory and industry changes and assessing impact on registrations and processes


✅ What we’re looking for

Essential:

  • Degree (or equivalent) in a scientific or engineering discipline
  • Minimum 1 year’s experience in Regulatory Affairs
  • Strong working knowledge of EU MDR 2017/745, UK MDR 2002, ISO 13485 & ISO 14971
  • Excellent written and verbal communication skills
  • Ability to work independently and collaboratively in a multi-disciplinary environment
  • Proficiency with MS Word, Excel, PowerPoint, and Adobe tools

Desirable:

  • Participation in internal auditing programmes
  • Experience with MDSAP countries and/or FDA registrations


Salary & Benefits

  • £32,000 - £42,000 (dependent on experience)
  • 33 days holiday (inclusive of bank holidays) plus holiday trading scheme
  • Pension
  • Life assurance
  • Plus additional benefits


Interested? Apply now or message me to find out more

Apply
Location:
Pontypridd
Job Type:
FullTime
Category:
Government

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