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Summary

Regulatory Affairs Specialist in Medical Devices area.

Experiences

Current Experience

  • Regulatory Affairs Specialist
    Since October 2014
    - Maintenance of CE technical files for medical products and assist in the improvement of the technical files - Coordination of the risk management process for medical devices to ensure compliance with regulatory requirements (Drafting / Reviewing Risk Management File) - Responsibility for maintenance and coordination of Post-Market Surveillance activity (Organising cross functional meetings, providing guidance, compiling information and drafting PMS Reports)

Past Experience

  • International Regulatory Affairs Officer
    August 2013 --- December 2013
    Achievement: Cosmetics - Preparing and maintaining up the dossiers for international registration/approval - Interpreting and preparing responses to health authorities questions - EU and international regulatory surveillance - Providing interpretations of regulation requirements to local distributors and subsidiaries

  • International Regulatory Affairs Officer LABORATOIRES
    April 2012 --- October 2012
    Food supplements - Preparing and maintaining up the dossiers for international registration/approval - Reviewing and approving labelling and advertising materials for compliance - Representing the Regulatory Affairs department on reformulation and news product's development projects - EU regulatory surveillance

  • Regulatory Affairs Officer
    July 2011 --- December 2011
    Feed supplements - Ensuring compliance of product range for companion animals with the new EU feed supplements regulation ; checking of formulas and labelling - Preparing technical dossiers - Approving and justifying claims on label products


  • February 2010 --- July 2010


  • February 2008 --- August 2008


  • May 2005 --- July 2005

Knowledge

LinkedIn Assessment :
Regulatory affairsRegulatory RequirementsRegulatory submissions

Education

  • Master’s Degree in Chemistry from Aix-Marseille Université in 2010

Area / Region

Portsmouth, United Kingdom

Others

Driving License
  • No