Latin America Regulatory Affairs Manager

Há 3 dias


São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro R$80.000 - R$150.000

We are seeking a skilled Regulatory Affairs Project Management Specialist to join our team in Latin America.

Job Description

The successful candidate will act as project manager on regional impact projects related to regulatory compliance and quality assurance, participating as an SME on global impact projects that require RA MedTech LATAM input. This role is responsible for ensuring alignment and harmonization of processes among the RA Team, working closely with the RA LATAM QC PoC and local RA QC PoCs.

Key Responsibilities:
  • Act as project manager on regional impact projects related to regulatory compliance and quality assurance on the Regulatory Affairs MedTech team.
  • Lead alignment and process improvement initiatives for the RA LATAM team, to gain efficiencies on RA team daily workload.
  • Act as SME for global impact projects that require Regulatory Affairs MedTech LATAM input.
  • Supports RA Operational Excellence manager on compliance-related activities as required.
Required Skills and Qualifications

The ideal candidate will have:

  • A University/Bachelor’s Degree or Equivalent within a technical related field.
  • 4-6 years of related experience on the regulatory affairs area, with experience on Medical Devices industry being desirable.
  • Certifications such as RAC or Certification in project management (PMP certification or similar) are a plus.
Benefits

This role offers:

  • Demonstrated understanding of the LATAM regulatory environment, including compliance, current and proposed laws, regulations and guidance.
  • Ability to communicate and guide internal teams and stakeholders on the decision-making process.
  • Capacity to contribute to the development of effective regulatory strategic plans that are in line with business objectives.
Others

The ideal candidate should also possess:

  • Quality Assurance mentality.
  • Strong interpersonal skills.
  • Project management skills (leading projects and working in simultaneous projects).
  • Problem solving skills and critical thinking.
  • Strong communication skills (verbal and written).
  • Attention to detail.
  • Familiarity with data management and analytics concepts and tools.

Languages: Spanish native/advanced; English advanced; Portuguese is a plus.



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