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Senior Regulatory Affairs Specialist

Job description

Senior Regulatory Affairs Specialist

You will provide leadership for the site for Regulatory Affairs for NPD projects and continue to do so as the company continue their strong growth.

 Responsibilities

  • Define data and information required for regulatory approvals and guide conformance in product development, content labelling and promotional materials.
  • Define best practice for regulatory affairs processes.
  • Utilise your deep scientific and technical understanding of regulated products to provide strategic guidance for life cycle management and product development.
  • Manage the transition to the new MDR requirements and ensure compliance to notified body requirements.
  • Develop labelling specifications and approve ant proposed labelling and packaging.
  • Provide regulatory support to project teams and provide support during internal and external audits. Similarly represent regulatory affairs on cross functional project teams.

 

Requirements

  • Must have a degree in science or engineering or a similar field with 5 years or more experience in the medical device industry and 2 or more in regulatory affairs.
  • Should have prior experience in submissions, international registrations and dossiers and delivering upon the regulatory strategy.

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