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Regulatory Affairs Associate

Posted 11 January by AES Ended

Position: Regulatory Affairs Associate

Location: Gloucestershire / Wiltshire Border

Salary: £Commensurate with Experience + Excellent Benefits

If there’s something stopping you from achieving all you’re capable of, you’ll relish a role with a company that will positively encourage you to be pro-active - a real opportunity to release your true potential.

The Company: Our Client, a leader in orthopaedic innovation, has pioneered many landmark orthopaedic developments improving lives through the introduction of ground breaking products. They are now looking to add to their already talented and dedicated workforce who share a common commitment - to deliver quality orthopaedic products and services to patients, surgeons and healthcare providers, which exceed their expectations.

Due to sustained continued expansion, my Client are looking to employ a Regulatory Affairs Associate to be responsible for the management and maintenance of the Regulatory Compliance including CAPA and RA coordination, compliance to ISO13485, and FDA21 CFR Part 820

The Person: Candidates suitable for consideration should be able to provide evidence of the following:

  • Working knowledge of the regulations and guidance for global markets including, but not limited to, EU, FDA, Canada, Australia, Japan, and other distributed markets.
  • Understanding of Quality Management Systems - FDA QSR, ISO 13485.
  • Graduate level or equivalent in a life science subject.
  • A minimum of 2 years previous experience. Ideally in medical device regulatory affairs.
  • Experience in orthopaedics is desired but not essential.

You will be self-motivated, have excellent communication skills both written and oral, be computer literate, and able to work as part of a team.

Do you have the courage to take on this challenge?

Required skills

  • CAPA
  • CFR
  • Regulatory Affairs
  • Regulatory Requirements
  • 13485

Reference: 33796342

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