Regulatory Affairs 6 Month Contractor

South Wales
£40 - £60 per annum
22 Feb 2013
22 Mar 2013
Joseph Dykes
Full Time

My Client inSouth Wales is now looking to develop their existing products in to the American market. Because of this they now have the need for a Regulatory Consultant to come in on an initial 6 month basis.

This Role Involves;

  • Constructing and leading an FDA regulatory strategy.
  • Writing and developing all technical documentation for Surgical Devices.
  • Regular interaction with FDA.
  • Putting together all relevant documentation for 510k submissions.

Required Experience;

  • 4+ year working within Medical Devices with a regulatory background.
  • Strong understanding of the FDA's procedures & policies,
  • The ability to put together a Strategic Regulatory Affairs plan for 510k submissions.
  • Good interpersonal and communications skills.

The successful individual will leading this businesses already established products in to theUSA, this means being consultative as well as being hands on and helping with the work involved. They want to start talks with the FDA yesterday but want to be sure they get it right first time.

If you believe you have the correct experience, or know someone who has then please contact me on 02077587322.

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