Regulatory Affairs Specialist

Responsibilities:

1. Lead the complete ANVISA product registration lifecycle, from documentation preparation to final approval, as the primary local regulatory contact.
2. Compile and maintain all regulatory technical files in compliance with Brazilian and international standards.
3. Develop and execute local regulatory and compliance strategies for market access.
4. Act as the key local liaison for all Quality Management System (QMS) matters, including coordinating with headquarters on compliance, audits, and corrective actions.
5. Manage all post-market regulatory activities, including vigilance reporting and product renewals.
6. Provide proactive regulatory guidance and support to local commercial and operational teams.
7. Maintain comprehensive regulatory and quality records in accordance with local requirements.
8. Monitor and communicate changes in Brazilian medical device regulations and standards.