QA and Regulatory Specialist - Leeds, United Kingdom - Kenton Black Science & Engineering

Kenton Black Science & Engineering
Kenton Black Science & Engineering
Verified Company
Leeds, United Kingdom

4 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
Medical device QA and Regulatory Specialist
Hybrid + West Yorkshire
Up to £38K depending on experience
A Medical device QA and Regulatory Specialist is needed in West Yorkshire.

This Medical device QA and Regulatory Specialist will have the fantastic opportunity to support quality regulations for producing medical devices for international business from WestYorkshire.

This Medical device QA and Regulatory Specialist will be in a full-time permanent role based at the site in West Yorkshire.


The role will involve:

  • Ensure regulatory documents are held to the current standards including ISO13485 and EC1223/200
  • International registration of Medical devices.
  • Provide first contact for specific international regulations and quality assurance.
  • Ensure packaging and labelling are checked and given the green light for SKU's holding international processes, keeping to quality and regulatory standards
  • Minimum 2 years of experience leading in a Quality Assurance or regulatory role.
  • Experience with ISO13485 and EC1223/200
  • A Cross-Functional environment experience.
  • Experience with labelling requirements for medical devices.
  • Microsoft Excel proficiency

Benefits:


  • Competitive salary
  • 25 days of holiday
  • Birthday off
  • Early Finishes
  • Health scheme
  • Company pension
  • 10% bonus scheme
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