Manager, Regulatory Affairs

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.
• Hands-on experience with ANVISA submissions, sanitary registrations, amendments, renewals, imports, and portfolio maintenance. Solid understanding of technical dossier requirements, safety and performance evidence, stability data, labeling, risk management, and quality documentation
• Knowledge of Good Manufacturing Practices, Good Storage and Distribution Practices, technovigilance, and post-market surveillance requirements.
• Familiarity with ISO 13485, ISO 14971, IMDRF, MDSAP, and international requirements applicable to reliance and medical devices and in vitro diagnostic products.
• Ability to interpret regulations, guidelines, regulatory agreements, and technical requirements, translating them into clear business actions.
• Advanced Excel and AI tools are desirable

Main Brazilian Regulations and References

• RDC No. 830/2023 — IVD Registration, Notification and Risk Classification
• RDC No. 665/2022 — Good Manufacturing Practices for Medical Devices and IVDs
• RDC No. 751/2022 — Medical Device Registration, Notification and Risk Classification
• RDC No. 657/2022 — Software as a Medical Device
• RDC No. 16/2014 — Company Operating Authorization
• RDC No. 860/2024 — Importer Authorization Updates
• IN No. 320/2024 — IVD Grouping and Family Rules
• RDC No. 741/2022 — Reliance and Optimized Review Pathway
• IN No. 290/2024 — Equivalent Foreign Regulatory Authorities for Reliance
• Decreto Estadual nº 6.911/1935 e Instrução Normativa DPCRD - 1, de 15-3-2021
• PORTARIA MJSP Nº 204, 223 de 2022 and NT N°07/2019-UPTC/NUCOP/DCPQ/CGCSP/DIREX/PF

Knowledge, Skills, Abilities

• Ability to lead cross-functional teams and prioritize critical regulatory activities.
• Clear and effective communication with health authorities, internal stakeholders, business partners, and senior leadership.
• Strategic thinking, risk-based decision-making, and ability to anticipate regulatory impacts.
• Strong organizational skills, project management capabilities, and documentation discipline.
• Negotiation, influencing, and decision-making skills in highly regulated environments.
• Analytical, collaborative, resilient, and solution-oriented mindset.