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Regulatory Affairs Executive

Salary undisclosed

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Responsibilities:

  • Involve in Innovation projects - Advice project team on regulatory aspects and changes that would affect product manufactured.
  • Prepare Product Technical File.
  • Involve in product registration - Prepare product registration documents for the requested countries, work with regulatory body/agency on required document for registration submission.
  • To apply for Free Sale Certificate & Manufacturing Certificate and arrange for legalization of certificates.
  • Work with HQ on Regulatory documents and Release order.
  • Support marketing on label changes and marketing material review.
  • Other regulatory task as assigned.

Requirements:

  • Degree in Science or Engineering.
  • Preferable with minimum 3 years' working experience in Regulatory Affairs.
  • Knowledge of ISO13485.
  • Knowledge of regulatory and registration document submission in Rest of World.
  • Personal - Committed with positive attitude, flexible, good accountability and good team spirit.

What can Ambu offer you?

Ambu is experiencing a very positive and exciting development. We are a dynamic and international workplace with skilled colleagues who emphasize freedom with responsibility and to have a good working environment.

Ambu’s ambitious growth objectives means that there is a natural focus on the ongoing development of your professional and personal skills that will help to ensure our continued success.

We offer a wide range of professional, social and economic benefits, in addition to the exciting challenges of the job, which adds to your job satisfaction.