Regulatory Affairs Specialist

The search and recruitment firm, Yes Human Resources, Inc. is looking for, Regulatory Affairs Specialists.

Responsibilities:

  • Write and manage regulatory submissions. This can include but not limited to regulatory regimes such as HSA, CE Mark, TGA, FDA.
  • Provide regulatory affairs support for all aspects of product development and product manufacturing.
  • Provide regulatory affairs support for clinical studies including pre-market, post-market and physician initiated studies.
  • Perform regulatory responsibilities independently with a minimal level of guidance and supervision.

Requirements:

  • Bachelor’s or higher degree in technical discipline.
  • Minimum of 3 years of regulatory affairs experience.
  • Prior knowledge of medical device regulations is an advantage.
  • Experience with regulatory support of clinical trials.
  • Excellent negotiation skills; written/oral communication skills.
  • Strong team player and ability to work in a fast pace and cross-functional organization.

Closing date: March 26, 2012

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