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.
Requirements:
* Bachelor's degree or higher in Life Sciences, Engineering, or a related field.
* Minimum 3 years of hands-on experience in medical device regulatory affairs within the Brazilian market.
* Proven track record of successful product registrations with ANVISA.
* In-depth knowledge of Brazilian regulations (e.G., RDC 751/2022) and key international standards (e.G., ISO 13485).
* Ability to work independently with minimal supervision, managing all local RA and QMS support matters effectively.
* Fluency in Portuguese (native/professional) and English (business proficiency).
* Excellent communication and stakeholder management skills, with the ability to interface effectively with authorities and internal teams.
* Strong organizational, problem-solving, and project management skills, capable of handling multiple priorities autonomously.