Regulatory Affairs Specialist

Responsibilities:

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

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