Work Flexibility: Hybrid

What You Will Do

As a key leader within the Regulatory Affairs team, this role is responsible for managing a team and ensuring regulatory compliance across multiple processes. Reporting to the Senior Manager, RAQA, the Associate Manager, Regulatory Affairs will oversee the management of new product registrations, renewals, and change notifications, ensuring compliance with local and international regulations. This position requires strong regulatory expertise, leadership skills, and the ability to collaborate cross-functionally to drive compliance and business continuity.

Lead and develop the Regulatory Affairs team, ensuring alignment with regulatory requirements, internal processes, and business objectives.Oversee the end-to-end management of new product registrations, renewals, and product change notifications, ensuring timely submissions and approvals.Ensure compliance with regulatory requirements, including certification maintenance (e.g., InMetro, Anatel, Anvisa), to guarantee continuous product availability.Act as the primary liaison with health authorities, participating in meetings, training sessions, and regulatory discussions to facilitate approvals.Partner with Marketing and cross-functional teams to align on regulatory strategies and prioritize new product submissions.Supervise the preparation and monitoring of the Regulatory Affairs budget, ensuring efficient resource allocation and providing quarterly updates to management.Ensure compliance with internal and external audits by maintaining accurate documentation and executing corrective action plans when required.Monitor and report key regulatory KPIs, providing insights and strategic recommendations to senior leadership.What you need:

Required:

Advanced level of EnglishStrong experience in Regulatory Affairs, specifically with RDC 751 (clases 1 to 4)Previous experience in medical device companiesPrevious experience in management positionsExperience with Anvisa

Preferred:

Previous experience with orthopedic productsAdvanced level of SpanishExperience with Inmetro and Anatel certifications

Travel Percentage: 10%