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.

Requirements:

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