Senior Regulatory Affairs Director

1 dia atrás

São Paulo, São Paulo, Brasil beBeeDirector Tempo inteiro R$45.000 - R$60.000
Regulatory Affairs Leadership Position

The successful candidate will lead our MedTech Regulatory Affairs team in Brazil, overseeing regulatory strategy and compliance across countries in the cluster.

This role involves working closely with other RA leaders and functions to ensure all marketed products meet regulatory requirements. The individual will provide relevant support, assign resources to complete submission plans, and obtain timely approvals.

The key responsibilities of this position include:

  • Leading the RA function across countries in the cluster
  • Ensuring accurate prioritization of submissions to meet plan
  • Head compliance with local regulations, Regulatory Authorities regulations, and Enterprise Quality Standards
  • Shaping the regulatory environment through focused policy and advocacy initiatives
  • Providing support and consultation to teams in other functions
  • Escalating and following up on concerns properly
  • Collaborating closely with Regional, Global, and Franchise Regulatory Affairs teams
  • Developing and ensuring implementation of RA SOPs

The ideal candidate will possess 10 years of experience within Regulatory Affairs, preferably in the Medical Device sector. They should also have a minimum of 4-year experience in a people management position, as well as knowledge of Medical Device requirements.

Additionally, the successful candidate should have previous experience in the Medical Devices industry and familiarity with local regulations and relationships with authorities such as Anvisa and InMetro.

Preferred qualifications for this position include:

  • Strong leadership skills
  • Excellent interpersonal, influencing, and communication skills
  • Ability to build partnerships internally and externally
  • Experience with organizational change
  • Analytical and critical thinking

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