Regulatory Affairs Specialist

Regulatory Affairs Specialist - Detalhes da Vaga. ● 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. ●. Requisitos para participar do processo. ● . O que oferecemos.