Job Description
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. <...