Manager, Regulatory Affairs - LATAM

Oxoid Remel Microbiology (Acquired from Thermo Fisher Scientific); São Paulo; Teletrabalho; BRL 300 000 - 420 000; Tempo integral

Resumo da oferta

Oxoid Remel Microbiology is seeking a Manager, Regulatory Affairs – LATAM to lead regulatory strategies across Latin America, ensuring compliance, timely market access and lifecycle management.

The role partners with global and regional teams to navigate ANVISA and LATAM requirements, directing registrations, post-market activities, and regulatory intelligence for IVDs, medical devices, and SaMD.

Qualificações

• Bachelor's degree or equivalent in Life Sciences, Engineering, Regulatory Affairs, or related field.
• Experience leading regulatory strategies, submissions, and cross-functional initiatives, preferably in LATAM.
• Deep knowledge of Brazilian ANVISA requirements and LATAM regulatory landscape.
• Hands-on experience with product lifecycle activities and regulatory intelligence.

Responsabilidades

• Provide regulatory leadership for LATAM across the Microbiology portfolio, ensuring compliance and timely market access.
• Develop and execute regional regulatory strategies for registrations, amendments, renewals, and labeling changes.
• Lead regulatory submissions, manage interactions with health authorities, and address deficiencies.
• Monitor LATAM regulatory developments and assess business impact.
• Guide post-market activities, including assessments and health authority notifications.
• Collaborate with stakeholders to align regulatory priorities with business needs.
• Maintain regulatory data, registrations, renewals, and commitments.
• Drive continuous process improvements in regulatory tools and workflows.
• Provide regulatory support to distributors and partners across LATAM.
• Collaborate with global/regional teams on new product introductions and portfolio changes.

Conhecimentos

Regulatory strategy

Stakeholder management

Cross-functional collaboration

Project management

Communication skills

Negotiation

Strategic thinking

English proficiency

Portuguese proficiency

Spanish proficiency

ANVISA knowledge

Formação académica

Bachelor's degree in Life Sciences

Ferramentas

Microsoft Excel

AI tools

Descrição da oferta de emprego

Joining Oxoid Remel Microbiology, you’ll play an active part in helping deliver meaningful impact. We play a crucial role in supporting accurate disease identification and targeted treatment, food and beverage safety, and pharmaceutical manufacturing integrity. Our products and services are designed to meet high standards of quality and performance, helping customers achieve their objectives efficiently and effectively.

As Manager, Regulatory Affairs – LATAM, you’ll provide regulatory leadership for our Microbiology portfolio across Latin America, helping ensure continued compliance, timely market access, and effective product lifecycle management. You’ll work closely with global and regional partners to navigate evolving regulatory requirements and support the continued growth of our business throughout the region.

This is a remote-based position located in São Paulo, Brazil, with responsibility for regulatory activities across Latin America.

About the Role

The Manager, Regulatory Affairs will provide regulatory leadership for the Oxoid Remel Microbiology portfolio in Latin America (LATAM), ensuring regulatory compliance, enabling timely market access, maintaining compliance throughout the product lifecycle, and providing regulatory guidance to internal stakeholders and business partners.

The role is responsible for developing and executing regional regulatory strategies covering new product registrations, lifecycle maintenance, licenses and permits, post-market regulatory activities, regulatory intelligence, regulatory systems management, and distributor and partner support.

The primary focus is ensuring that the Microbiology product portfolio complies with applicable health authority requirements for in vitro diagnostic (IVD) products, medical devices, instruments, and Software as a Medical Device (SaMD), as well as other applicable regulatory requirements.

The position sits within the Oxoid Remel Microbiology Global Regulatory Affairs team and reports to the Director, Global Regulatory Affairs. Key stakeholders include Regulatory Affairs, Quality, Supply Chain, Commercial, Legal, Marketing, Manufacturing, Product Management, and external distributors and business partners.

What You Will Do

• Ensure regulatory compliance and market authorization of the LATAM Microbiology portfolio, including registrations, licenses, permits, certificates, and lifecycle maintenance.
• Develop and execute regulatory strategies for new registrations, amendments, renewals, imports, product transfers, line extensions, and labeling changes aligned with business priorities.
• Lead and/or execute regulatory submissions, including dossier preparation and review, coordination with manufacturing sites, submissions to health authorities, and resolution of authority questions and deficiencies.
• Monitor regulatory developments across LATAM, particularly in Brazil and other priority markets, assess potential business impact, and implement appropriate actions to maintain compliance and business continuity.
• Ensure regulatory compliance of post-market activities, including regulatory assessments, reportability determinations, and health authority notifications, in partnership with Quality and other relevant functions.
• Partner with key stakeholders to establish priorities, communicate regulatory requirements and risks, and align regulatory activities with business needs.
• Maintain accurate regulatory data and systems, ensuring visibility of registration status, renewals, commitments, and key regulatory activities.
• Drive continuous improvement of regulatory processes, tools, and ways of working to increase efficiency and maintain compliance.
• Provide regulatory guidance and support to distributors and business partners throughout the LATAM region.
• Collaborate across functions and regions to support new product introductions, product changes, and ongoing portfolio management.

What You Will Bring

Minimum Qualifications

• Bachelor’s degree, or equivalent experience and qualifications, in Life Sciences, Engineering, Regulatory Affairs, or a related field.
• Typically 8+ years of progressive Regulatory Affairs experience, including experience leading regulatory strategies, submissions, cross-functional initiatives, and/or regulatory teams.
• Significant experience with IVD products and/or medical devices in Brazil, with strong knowledge of Brazilian regulatory requirements and the ability to navigate regulatory requirements across LATAM.
• Hands‑on experience with ANVISA submissions and product lifecycle activities, with a solid understanding of technical documentation and applicable regulatory requirements.
• Familiarity with relevant international standards and regulatory frameworks applicable to medical devices and in vitro diagnostic products.
• Ability to manage multiple projects and priorities simultaneously.
• Strong communication, negotiation, and influencing skills.
• Strategic thinking and risk‑based decision‑making capabilities.
• Strong organizational and project‑management skills with excellent attention to detail.
• Analytical, collaborative, and solution‑oriented mindset.
• Ability to work effectively across global and regional teams in a remote environment.
• Strong stakeholder‑management skills with the ability to communicate regulatory requirements and risks to both technical and business audiences.
• Strong English, Portuguese, and Spanish language skills.
• Advanced Microsoft Excel skills.
• Familiarity with AI tools is desirable.

Location

This is a remote-based role located in São Paulo, Brazil. The position will work closely with colleagues and stakeholders across Latin America and the broader global organization, requiring flexibility to collaborate across regions and time zones.

Join Us

This is an exciting time to join Oxoid Remel Microbiology as we continue building on our established expertise and long‑standing reputation in microbiology. With a broad portfolio, global capabilities, and teams working across multiple markets, we’re focused on delivering high‑quality solutions that support our customers and the communities they serve.

In this role, you’ll have the opportunity to shape regulatory strategy across Latin America, partner with colleagues around the world, and help ensure our products continue reaching customers in a compliant and timely manner.

If you’re an experienced Regulatory Affairs professional who understands the complexities of ANVISA, Brazil, and the broader LATAM regulatory environment and enjoys turning regulatory requirements into practical business solutions, we’d love to hear from you.