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Medical Device QA and Regulatory Specialist

4 months ago

Leeds, Leeds, United Kingdom Kenton Black Full time
Medical device QA and Regulatory Specialist

Hybrid + West Yorkshire

Around £35K 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 West Yorkshire.

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

Job Types:
Full-time, Permanent

Salary:
From £35,000.00 per year

Benefits:

  • Free parking
  • Private medical insurance

Schedule:

  • Monday to Friday

Supplemental pay types:

  • Bonus scheme

Ability to commute/relocate:

  • Leeds: reliably commute or plan to relocate before starting work (required)

Experience:

  • Quality assurance: 2 years (preferred)
  • ISO 13485: 2 years (preferred)

Work Location:
One location