**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 Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.