Analista de Assuntos Regulatórios
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
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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.
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
At Materialise, we’re committed to nurturing the professional development of our employees. We invest in our passionate people and empower them to explore and grow by offering diverse career paths that capitalize on their talents. Plus, we offer courses, external coaching programs, and in-house mentoring so that our employees can fulfill their potential.
Team building
We cultivate a positive work culture so our employees have an enjoyable professional environment. Collaboration is key, so we organize activities that unite our employees, such as after-work events and team lunches. We want all our staff to feel connected in an environment that promotes strong bonds based on trust, respect, empathy, and friendship.
Innovation is key
Innovation is not just a buzzword at Materialise; it's at the core of what we do. As pioneers in our industry, we create cutting-edge solutions, fostering an environment that supports and rewards ingenuity and leadership. We’re dedicated to shaping the future of 3D printing, recognizing and celebrating the creative spirit within all our global innovators.
Hybrid working & flexibility
At Materialise, we value the power of in-person connections and the advantages of remote work, allowing our employees the flexibility to enjoy the best of both worlds. You can work remotely up to 60% of the time and work flexible hours, depending on your particular role.
