Analista de Assuntos Regulatórios

Brazil Job Openings

Materialise

Rio Claro

FULL TIME

August 26, 2024

Analista de Assuntos Regulatórios

RIO CLARO, BRAZIL
QUALITY
ON-SITE
FULL-TIME

O nosso Analista de Assuntos Regulatórios elabora processos de registros e cadastros, monitoramentos na Anvisa, atualização de normas e instrução de uso, cadastros no sistema, controle de exigências e revalidações. Se você tem pensamento crítico e gostaria de atuar em um ambiente que busca melhoria contínua, inscreva-se!

What you will do

Interface empresa – agências reguladoras;
Acompanhamento e suporte na documentação técnica para registros e elaboração de relatórios técnicos;
Peticionamentos e pagamentos;
Elaboração e controle de instruções de uso e rotulagem;
Autorização do envio da documentação de registro para a Agência Reguladora;
Acompanhamento de processos e prazos de registro;
Análise dos processos de revalidação de registros fazendo o monitoramento de datas de publicações do DOU;
Monitoramento investigativo, sob supervisão do Responsável pela Tecnovigilância;
Elaboração dos documentos para solicitação de Emissão / Renovação do Certificado de Boas Práticas de Fabricação ANVISA e Licença de Funcionamento junto a Visa Local.

Your profile

Experiência anterior na área de dispositivos médicos.
Ensino Superior Completo
Conhecimento Mínimo em Legislações Pertinentes na Área
Pacote Office - Intermediário
Inglês intermediário
Senso crítico
Visão sistêmica e analítica
Trabalho em equipe
Atenção a prazos
Boa comunicação
Proatividade
Comprometimento

Location and type of contract

Rio Claro, Brazil
Full-time
On-site
Associate level

Working at Materialise

Materialise is a dynamic, international high-tech company, founded in 1990 and headquartered in Belgium, with over 2,300 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research, and academia.

As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.

More information

What we offer

Healthy life-work balance

When creating a better and healthier world, a good place to start is with yourself. That's why we encourage our employees to prioritize their overall well-being, fostering physical fitness, mental resilience, and social connections through a range of workshops, sports activities, and other events and initiatives that contribute to a balanced and fulfilling work-life harmony.

Personal growth and career advancement

Team building

Innovation is key

Hybrid working & flexibility

We regret to inform you that this job opportunity is no longer available as it has expired

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