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Regulatory Affairs Assistant

Posted 27 October by PE Global Ended

Job purpose:
To support product registration activities and product registration submissions throughout the world, in order that registrations are achieved in a timely manner in accordance with regulatory and Company requirements 

Principal Accountabilities:

  • Provide full support to all registration activities and regulatory submissions throughout the world.
  • Facilitate worldwide product registration activities by compiling appropriate dossiers, submissions and responses to regulatory bodies.
  • Maintain information on worldwide regulatory requirements and the status of product registrations.
  • Liaise with all departments and project teams to co-ordinate timely applications for regulatory approvals.
  • To be aware of progress and developments of worldwide regulatory requirements.
  • To follow and promote Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results.

Qualifications And Experience:

  • A good first degree in a relevant scientific discipline, or equivalent.
  • Significant regulatory experience covering medical devices.
  • Commanding knowledge of worldwide regulatory procedures, especially for medical devices.
  • Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements
  • Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
  • Possess computer competency in Microsoft office software, data collection and general analysis tools.

Special Aptitudes:

  • Excellent PC skills (Microsoft Office Package).
  • Excellent written and verbal reasoning skills. 


  • Excellent planning and organisational skills.
  • Communication - listener, learner and thinker.
  • Product awareness and thorough knowledge of respective regulatory frameworks.
  • Thorough and flexible.
  • Cross culturally aware.
  • Team player
  • Enthusiastic and committed.

Reference: 33656422

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