Regulatory Affairs Associate

Posted 22 January by Harris Lord Group

Regulatory Affairs Associate
Medical Devices - Berkshire
£30,000 - £35,000

Our client is a fast growing Medical Device company that is going through rapid year and year growth.

They have developed a ground breaking product that has endless medical applications and a constant growth of clinical data to back up the technology.

The Regulatory Affairs Associate will be responsible for directly submitting and maintaining regulatory approvals, under the direction and guidance of the Head of Q&RA.

Specific Responsibilities

o Leading the preparation and submission of regulatory approvals in the markets served. Including (but not limited to): EU, USA, China, Canada, Australia, New Zealand, Israel, Middle East, Korea

o Participating in ensuring compliance with all applicable standards and regulations for the companies medical devices

Experience, Skills and Abilities

  • Strong background in regulatory affairs for medical devices, with at least 5 years of relevant experience.
  • Experience in the medical devices industry essential
  • Good knowledge and experience of EU regulations and guidance required
  • Good knowledge of ISO13485 and ISO14971 highly desirable
  • Experience of FDA 510(k) submissions highly desirable
  • Experience of regulations in Asia, Canada, Australia, Middle East desirable
  • Educated to degree level in a relevant discipline
  • Good time management, thoroughness, attention to detail and organisational skills.
  • Excellent communication skills, both verbally and in writing, using correct terminology with staff and partners at all levels.
  • Self-motivated and able to work independently, but to do so in the context of the wider team.
  • Able to understand the context of their role within the commercial objectives of the company, and have the necessary degree of pragmatism, flexibility and sense of urgency to succeed in a small company environment.

If you are interested in this role please click apply now.

Harris Lord is acting as an employment agency for this role.

Keywords: regulatory affairs, reg affairs, RA, medical devices, iso13485, 13485, engineering,

Required skills

  • FDA
  • Medical Devices
  • Regulatory Affairs
  • Regulatory Approvals

Reference: 34291528

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