Regulatory Affairs Assistant LATAM
Michael Page
hace 21 días

Descripción de la vacante

The principal responsibilities are to :

  • Work closely with Marketing, R&D, Manufacturing, and Clinical Affairs, develop the regulatory strategy to gain market approval for new or modified devices / combination products consistent with corporate objectives
  • Interact proactively and persuasively with global regulatory agencies in order to gain approvals
  • Provide oversight of regulatory assessments for all document, product, and process changes to ensure that change notifications to regulatory bodies are appropriately submitted
  • Ensure all national registrations, licenses, listing, and other certifications are maintained as required for regulatory compliance
  • Train company employees on compliance with quality system standards
  • Participate with the management team in developing and implementing relevant business and strategic plans
  • Ensure company is regulatory inspection (FDA, Notified Body, international regulatory bodies, corporate) ready at all times
  • Plan, coordinate and direct regulatory strategies for new products
  • Manage regulatory affairs, quality control, quality assurance, calibration, complaint handling and document control staff
  • Develop and implement quality system management strategies and plans to include resources, systems, time lines and financial that support, contribute to and integrate with company's annual and long term business strategy
  • Perfil del candidato

    BA / BS in the life sciences, or engineering with MS preferred. Requires 5+ years of regulatory experience in the medical device / pharmaceutical / biologic industry.

    Requires experience developing and successfully defending complex regulatory submissions for medical devices. Extensive experience working with the FDA regarding inspections, submissions and follow up.

    Oferta de empleo

  • Attractive salary package
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