Regulatory Affairs Analyst (Hybrid)

Stryker Group; São Paulo; Presencial; BRL 80.000 - 100.000; Tempo integral

Resumo da oferta

A leading company in the medical devices industry is seeking a Regulatory Affairs Specialist to ensure compliance with regulations and manage product registrations. The role involves interaction with health authorities and cross-functional teams to maintain high standards. Candidates should possess a Bachelor's degree in a healthcare-related field and have relevant experience in regulatory affairs.

Qualificações

• Experience in regulatory submissions and product registrations.
• Knowledge of Ordinance 384/2020 and RDC 751/2022.

Responsabilidades

• Manage regulatory submissions and product registrations.
• Prepare and submit dossiers to health authorities.
• Provide regulatory updates to marketing and international teams.

Conhecimentos

Compliance

Regulatory Affairs

Cross-Functional Communication

Analytics & KPIs

Formação académica

Bachelor’s degree in a healthcare-related field

Ferramentas

Microsoft Office Suite

Descrição da oferta de emprego

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