Regulatory Affairs Specialist

2 semanas atrás

Blumenau, Brasil Grupo Selecionar Tempo inteiro

**As a regulatory specialist**, you are part of a motivated and self-propelled team which is part of a global regulatory team. You will work closely with other business areas including quality assurance, privacy and security in a fast-paced dynamic software environment.

You are responsible for:

- Providing leadership and project management for regulatory deliverables as directed by manager.
- Regulatory planning for new product introductions and product updates.
- Advising product design teams on regulatory strategy and requirements for updated and/or new products.
- Being involved in developing, modifying and executing company regulatory policies that affect immediate operations.
- Facilitating communication and leveraging of best practices as applicable.

To succeed in this role, you should have the following skills and experience
- Preferably bachelor’s degree in Pharmacy and/or a science related field
- Advanced in English language is a must
- Experience in the medical device industry (EU MDD/MDR, Health Canada, China, US FDA, etc.)
- Proficient knowledge of domestic and international standards. Experience with Software as a Medical Device (SaMD) is preferred - not required
- Must be able to manage multiple tasks and perform with accuracy and a high attention to detail.
- Experience in Design Controls would be preferred
- Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with mínimal supervision.
- Familiarity of medical device regulations (EU MDR, 21CFR/FDA, etc.) and other global laws, regulations and standards including ISO 13485, ISO 14971 and other related regulatory and quality standards.

Tipo de vaga: Temporário
Duração do contrato: 9 meses

Salário: R$70,00 - R$90,00 por hora

Escolaridade:

- Ensino Superior completo (preferencial)

**Experiência**:

- Regulatory Affairs Specialist (preferencial)

Idioma:

- Inglês (preferencial)

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