
Medical Device Registration Professional
Há 15 horas
We are seeking a skilled Regulatory Affairs Specialist to join our Medical Devices team.
This role involves executing registration strategies for designated regional projects related to new/existing products, adhering to local regulation and approved licenses.
The ideal candidate will have a Bachelor's degree in a health-related field and at least 1 year of experience in regulatory affairs. Fluent Portuguese and advanced English skills are required, with intermediate Spanish as an asset.
This position requires result-oriented individuals with good communication skills, able to handle multiple projects and work collaboratively as part of a team.
Main Responsibilities:
- Execute registration strategies for designated regional projects
- Ensure compliance with regulatory agency regulations and interpretations
- Prepare responses to regulatory agencies' questions and correspondence
- Partner with other functions to define and obtain regulatory deliverables
- Maintain and archive all regulatory documentation
Requirements:
- Bachelor's degree in a health-related field
- At least 1 year of experience in regulatory affairs
- Fluent Portuguese and advanced English skills
- Intermediate Spanish as an asset
- Result-oriented with good communication skills
- Able to handle multiple projects and work collaboratively
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