Sr Analyst in Regulatory Affairs - DePuy Synthes
Johnson & Johnson
DePuy Synthes seeks a Senior Analyst in Regulatory Affairs to develop and implement compliance strategies for medical devices in Brazil. The role involves interpreting regulations, analyzing scientific data, preparing regulatory submissions, and supporting cross-functional teams to bring new and modified products to market.
Responsibilities
- Ensure product compliance with Brazilian and international regulatory agency requirements
- Analyze scientific data and develop regulatory strategies to accelerate product market entry
- Prepare detailed regulatory submissions and supporting documentation for approvals
- Contribute to product labeling, claims validation, and promotional materials reviews
- Coach junior team members on regulatory processes and best practices
Requirements
- Minimum 3 years of regulatory affairs experience in Brazil
- Background in medical devices or pharmaceuticals
- Bachelor's degree in engineering, pharmacy, or life science
- Advanced English proficiency; fluent in Portuguese
- Knowledge of regulatory submissions and compliance strategies
- Experience with risk assessment and regulatory strategy development
- Orthopedics portfolio experience preferred
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