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Regulatory Affairs Associate

3 meses atrás

São Paulo, São Paulo, Brasil Zimmer Biomet Tempo inteiro

Requisition Number:
AMER28270

Employment Type:
Full-time

Location:
Sao Paulo

Job Summary:
A Zimmer Biomet é líder mundial em soluções de saúde musculoesquelética.

Os membros de nossa equipe fazem parte de uma empresa com herança de liderança, foco em moldar o futuro e uma missão dedicada a aliviar a dor e melhorar a qualidade de vida das pessoas em todo o mundo.

Esta posição requer uma avançada compreensão dos dispositivos médicos e seu uso, bem como uma compreensão do processo de submissão regulatória.


Principal Duties and Responsibilities:
Avaliar o risco das estratégias regulatórias propostas e oferecer soluções.
Avaliar propostas de mudanças nos registros dos produtos e comunicar o impacto regulatório no Brasil.

Elaborar e manter o controle de processos de registro de produtos, renovações, alterações pós-registro, cumprimentos de exigência e solicitações de Boas Práticas de Fabricação.

Contatar responsáveis pelos produtos em outros países para solicitar a documentação necessária dos processos citados acima de acordo com a legislação sanitária vigente.

Analisar e informar o impacto das publicações em Diário Oficial tanto de registro de produtos quanto de novas legislações aplicáveis Participar de Consulta Públicas de novas legislações aplicáveis, de reuniões de associações das empresas e de encontros com o setor regulado.

Acompanhar os processos de Certificação INMETRO e ANATEL, desde os contatos com os organismos certificadores reconhecidos, até agendamento e realização de inspeções internacionais das fábricas dos equipamentos sob certificação compulsória.

Efetuar e manter a regularização da empresa frente às autoridades sanitárias.
Dar o suporte regulatório necessário para a devida importação dos produtos. Comunicação com as agências reguladoras.
Manter sistemas, bases de dados e indicadores atualizados.
Acompanhamento e apoio ao marketing na elaboração, correção e aprovação de material promocional.

Expected Areas of Competence:
Fortes habilidades de escrita e comunicação
Fortes habilidades interpessoais e atenção aos detalhes
Capacidade de se comunicar efetivamente em vários níveis, inclusive com agências reguladoras
Capacidade de gerenciar várias prioridades concomitantes; versatilidade, flexibilidade e vontade de trabalhar com as mudanças de prioridades
Domínio de regulamentos pertinentes a dispositivos médicos bem como se manter atualizado acerca das novas legislações
Capacidade de identificar o risco em estratégias regulatórias
Habilidade de saber trabalhar em equipe, tendo proatividade e criando um bom ambiente de trabalho
Habilidades analíticas e de negociação, além de capacidade para resolução de problemas.

Education/Experience Requirements:
Graduação em nível superior
Experiência anterior em Assuntos Regulatórios
Experiência em submissão regulatória / Conhecimentos em legislação dos produtos para saúde.
Inglês avançado
Espanhol desejável

Travel Requirements:
Até 10%

Additional Information:
Acreditamos no "The Power of Us", o que significa que somos mais fortes juntos. Estamos comprometidos em criar um ambiente onde cada membro da equipe se sinta incluído, respeitado, empoderado e celebrado.

Como membro da equipe Zimmer Biomet, você irá partilhar o nosso compromisso de proporcionar mobilidade e vida renovada às pessoas em todo o mundo.

É por isso que oferecemos a você um pacote de remuneração competitivo, que inclui assistência médica, odontológica, vale-refeição, vale-alimentação, incentivos para desenvolvimento, entre outros.