Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
How will you make an impact? (Objective)
Lead the regulatory strategy and ensure regulatory compliance for Thermo Fisher Brazil’s operations, including product registration, lifecycle maintenance, licensing, post-market compliance, regulatory systems management and business support. This role ensures that medical devices, in vitro diagnostic, instruments, SaMD, animal health, chemical under special control and other products from Brazil portfolio comply with ANVISA, MAPA, ANATEL, Civil, Federal Police and Army requirements, Brazilian health legislation, and corporate quality standards.
What will you do? (Responsibilities)
- Ensure regulatory compliance of Thermo Fisher Brazil’s operations, products, licenses, certificates, sanitary permits, internal systems, warehouse and related processes, improving efficiency and productivity.
- Execute regulatory strategy for new product registrations, amendments, renewals, imports, product transfers, line extensions, labeling changes, and portfolio maintenance in Brazil according to business demands
- Manage full regulatory submission process, including product registration strategy, technical dossier preparation, contact with manufacturing sites, review of technical documentation, document translation, submission to the competent authority, and follow-up on questions, deficiencies, or additional requirements.
- Guarantee maintenance of regulatory database and provide periodical reports, including JDE, RegDesk and DocNix regulatory information
- Monitor Brazilian and international regulatory updates, conduct impact assessments, and implement action plans to maintain business continuity and regulatory compliance.
- Partner with Quality, Supply Chain, Commercial, Legal, Marketing, Manufacturing Sites, Product Manager, Service, Channel Managers, IT in a good and strategic way, setting priorities and clear communication.
- Manage Regulatory Affairs team in Brazil
- Lead specific projects cross regional
How will you get here?
- Bachelor’s degree in Pharmacy, Chemistry, Biomedical Engineering, Biology, Biotechnology, Medicine, Health Law, or a related field.
- Minimum of 8 to 10 years of experience in Regulatory Affairs, with at least 3 to 5 years in leadership roles.
- Proven experience with medical devices, in vitro diagnostic products and SaMD in Brazil.
- Advanced English and intermediate Spanish are mandatory for interaction with manufacturers site and LatAm teams.
- Strong knowledge of Brazilian legislation applicable to medical devices and in vitro diagnostic products, instruments, SaMD, animal health products, chemical under special control and ANATEL.