Manager, Regulatory Affairs

Work Schedule

Environmental Conditions

Job Description

How will you make an impact (Objective)

Lead the regulatory strategy and ensure regulatory compliance for Thermo Fisher Brazils 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 Brazils 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

• Bachelors 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
• PORTARIA MJSP Nº 204 223 de 2022 and NT N07/2019-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.