Experience

• 

  Promedon Argentina

  • Argentina
  • Medical Device
  • 1 - 100 Employee

  • Regulatory Affairs Sr. Analyst

    • Feb 2015 - Present

    - Manage product registration approval, at international markets (EuropeanUnion, Brazil, Mexico, and other Latin-American countries) according to thecorresponding regulatory framework.- Analyse, coordinate, and advise on regulatory matters in accordance withcurrent regulations and standards.- Maintain registrations of current products.- Discuss and develop strategies for products approval in different markets- Prepare, maintain, and update product dossiers.- Define the regulatory requirements related to the company's projects.

  • Quality Assistant

    • Feb 2008 - Feb 2015

    - Maintain and improve the implemented quality management system according EN ISO 13485.- Management of corrective and preventive actions.- Customer complaints.- Management of monitoring and measuring devices.- Inspections and tests at internal laboratory.- Supplier and internal audits.- Approval and inspection of raw materials at incoming reception controls.Product control at production line. Inspection, and final approval ofproduction batches.- Trademarks and patents management.

• 

  CNEA

  • Provincia de Buenos Aires, Argentina

  • Process Engineer

    • Aug 2006 - Jan 2008
    • Provincia de Buenos Aires, Argentina

    RAW MATERIALS PRODUCTION AREA - URANIUM PRODUCTION TECHNOLOGY DEPARTMENT.- Conceptual and basic designs of processes and their equipment.- Processes and technologies in use.- Industrial effluent treatment and remediation of environmental liabilities.- Development and review of technical documentation.- Basic engineering of transportable uranium concentration pilot plant.

• 

  CÓRDOBA SCIENCE AGENCY

  • Córdoba, Argentina

  • Intern

    • Apr 2005 - Mar 2006
    • Córdoba, Argentina

    STRATEGIC PLANNING AREA. QUALITY MANAGEMENT AREA- Application of procedures within the framework of the Total QualityManagement Program according to ISO 9001 and ISO/IEC 17025.- Control and revision of internal documentation (instructions, specifications,procedures and records).SPECIAL PROJECTS AREA- Coordination of special projects of the Córdoba Science Agency.