Medical Device Regulatory Specialist
Há 5 dias
We are seeking a skilled professional to support our Regulatory Affairs team in Brazil. This role involves preparing submission and registration documents for new or existing product offerings.
Key Responsibilities- Stay up-to-date with regulatory processes, guidelines, and guidance documents to ensure compliance.
- Collaborate with internal stakeholders to facilitate communication and data exchange.
- Work with various departments to collect and organize required documentation materials.
- Maintain accurate records in regulatory databases through data entry, remediation, and maintenance.
- Assist in compiling new or revised medical device submissions and dossiers for import permits.
- Develop knowledge of domestic and Latin American regulatory requirements for medical devices.
- SUPPORT THE REGULATORY IMPACT ASSESSMENT PROCESS AND DISCUSS ABOUT GAP ASSESSMENTS REGARDING REGULATORY UPDATES.
- Proven experience in regulatory affairs, preferably in the medical device industry.
- Strong understanding of regulatory processes and guidelines.
- Excellent communication and collaboration skills.
- Able to work accurately and efficiently in a fast-paced environment.
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