São Paulo, BRA
33 days ago
Regulatory Affairs Analyst (Hybrid)
**What you will do** + **Compliance** : Act in accordance with laws and regulations (such as FCPA) and Stryker’s Code of Conduct, upholding the highest ethical standards. + **Regulatory Affairs** : Responsible for product registrations, item maintenance, certifications (INMETRO, ANATEL), and supporting import clearance processes. + **Product Registrations** : Prioritize, plan, and manage regulatory submissions for changes, and renewals across all risk classes (I–IV), including GMP, INMETRO, and ANATEL certifications. + **Interaction with Health Authorities** : Prepare and submit dossiers, respond to ANVISA inquiries, and actively monitor approval status. + **Cross-Functional Communication** : Provide regulatory status updates to local Marketing teams and international RA teams, ensuring alignment across processes. + **Audit & Tender Support** : Participate in internal and corporate audits, providing regulatory documentation and supporting corrective actions when needed. + **Analytics & KPIs** : Deliver accurate data for monthly KPIs and management reports, identifying continuous improvement opportunities. + **Documentation & Procedures** : Maintain organized RA intelligence files, identify the need for new SOPs, and support process development in Regulatory Affairs.​ **What you will need** + Bachelor’s degree in a healthcare-related field + Experience with Microsoft Office Suite + Knowledge and experience with **Ordinance 384/2020** , **RDC 751/2022** , and preferably **Quality Standard 665/2022** + Previous experience in the **medical devices industry** (required) + Intermediate to advanced English proficiency + 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.
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