What you will do

• Regulatory Compliance: Ensure all activities comply with applicable laws, including the Foreign Corrupt Practices Act (FCPA) and Stryker's Code of Conduct, upholding the highest ethical standards.

• Product Registrations: Prioritize, plan, and manage regulatory submissions for new products across all risk classes (I–IV), including GMP, INMETRO, and ANATEL certifications.

• Agency Interaction & Submissions: Prepare and submit documentation to health authorities, respond to deficiency letters, and participate in meetings or discussions to support approvals and maintain relationships.

• Change Management: Review, assess, and approve change notifications (CNs), manufacturing changes, and regulatory impact evaluations in collaboration with international RA teams.

• Cross-Functional Collaboration: Communicate status updates to local Marketing and global RA teams, support tender and import operations with timely regulatory documentation, and maintain product data in internal systems.

• Audits & Quality Support: Participate in internal and corporate audits, provide RA documentation, and support action plan implementation as needed.

•  Process Improvement & SOPs: Identify regulatory procedure gaps, support development of new SOPs, and promote continuous improvement within RA and QA functions.

• KPI & Training Support:Provide accurate KPI data for monthly reporting, support management analysis, and contribute to the creation and updating of relevant training materials.

What you will need

• Bachelor’s degree in a healthcare-related field

• Experience with Microsoft Office Suite

• Previous experience in the medical devices industry (required)

• Experience with INMETRO and ANATEL certifications

• Solid knowledge of Ordinance 384/2020 and IN 283/2024

• Familiarity with regulatory frameworks: RDC 751/2022, RDC 848/2024, and RDC 579/2021

• Desirable: knowledge of Quality Standard 665/2022

• Advanced English; Spanish is a plus