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
Travel Percentage: 10%