Regulatory Affairs Specialist

hace 2 semanas


Juárez, Chihuahua, México BEPC Inc A tiempo completo

Regulatory Affairs Specialist

  • Develop and maintain regulatory strategies for the development, registration, and commercialization of
    medical devices:
  • Communicate with regulatory authorities to obtain timely approvals for medical devices
  • Review and approve labeling, marketing, and promotional materials to ensure compliance with regulations
  • Monitor regulatory changes and provide guidance to crossfunctional teams on potential impact to business
  • Participate in crossfunctional teams to ensure regulatory compliance throughout the product lifecycle
  • Assist with the preparation and conduct of regulatory inspections and audits
  • Maintain regulatory files and ensure documentation is uptodate and accurate

Qualifications:

  • Bachelor's degree in a scientific discipline
  • 3+ years of experience in Regulatory Affairs in the Medical Device industry
  • Strong understanding of US and international regulations related to medical devices, including FDA, EU MDR, and other global regulations
  • Experience preparing and submitting regulatory filings for medical devices
  • Excellent communication, organizational, and analytical skills
  • Ability to work independently and in a team environment
  • Strong attention to detail and ability to manage multiple projects simultaneously.
  • Advanced English 90%

Tipo de puesto:
Tiempo completo

Salario:
$ $200.00 al mes

Horario:

  • Lunes a viernes

Prestaciones:

  • Seguro de gastos médicos mayores


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