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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) - 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

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