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Interim (or Permanent) Regulatory Affairs Associate : Medical Devices

Our client is a well-financed, UK-based company operating within the medical devices sector and with plans to move to profitability within the next couple of years on the back of a number of product launches.

The company currently has over 20 employees including a strong technical team (of which the Regulatory Affairs function is a key part) led by a Chief Technology Officer (CTO). To underpin ambitious growth plans and build greater depth and expertise in the team, the company is seeking to appoint a Regulatory Affairs Associate with experience of regulatory affairs in relation to medical devices.

This is a crucial role for the successful expansion of the company into a substantial business over the next several years so the job holder will have a high level of influence in shaping the success of the business as it goes forward.

The Regulatory Affairs Associate role report directly to the Head Of Quality &Regulatory affairs. It is likely that the regulatory function will continue to grow.

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

Specific Responsibilities

  • Leading the preparation and submission of regulatory approvals in the markets served by the company. These include (but not limited to): EU, USA, China, Canada, Australia, New Zealand, Israel, Middle East, Korea
  • Participating in ensuring compliance with all applicable standards and regulations for the company’s medical devices

 Rapid expansion into new markets and territories along with the launch of new product upgrades are planned, requiring new and amended regulatory clearances.

 

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
  • 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.

 

This interim opportunity will be of a initial 6-months duration and will demand 3-4 days / week.  It is highly likely that a subsequent transition into a position of employment could follow if so desired.

If this opportunity is of interest, please contact Geoff Newman of Interea as soon as possible.




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