Senior Regulatory Affairs Specialist

Posted 16 January by AES

Position: Senior Regulatory Affairs Specialist

Location: Gloucestershire / Wiltshire / Oxon Border

Salary: £50,000 to £60,000 + 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 Senior Regulatory Affairs Specialist to act as a senior member of a Global Regulatory Affairs team, reporting to the Global Regulatory Affairs Manager, and acting as a vital part of a very fast paced and demanding team, covering all regulatory aspects across a full range of devices. You will be involved in European and USA regulatory affairs and will be responsible for all aspects of the product from NPD to launch. Primary tasks are to include Product Registration and regulatory aspects of post market surveillance.

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

  • Educated to degree level in a science subject (or equivalent).
  • Detailed 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.
  • A minimum of 3 years previous experience. Ideally in medical device regulatory affairs.

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
  • Medical Devices
  • Orthopedic
  • Regulatory Affairs
  • 13485

Reference: 33829755

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