Manager, Regulatory Affairs Brazil - DEPUY SYNTHES
On-siteSão Paulo, São Paulo, Brazil
Job Summary
Lead and manage regulatory submission, approval, and lifecycle activities for medical devices in the Brazil market. Develop and execute regulatory strategies supporting new product introductions, product changes, and ongoing compliance. Prepare, submit, and maintain regulatory dossiers, registrations, renewals, and notifications while acting as the primary liaison with Brazilian health authorities. Interpret regulatory requirements, communicate risks and timelines to internal stakeholders, and partner with Quality, Supply Chain, R&D, and Commercial teams to ensure compliance throughout the product lifecycle. Support regulatory inspections, audits, and inquiries, ensuring accurate responses and timely resolution of commitments. Provide guidance, coaching, and day-to-day direction to regulatory team members or project contributors.
Required Qualifications
- Bachelor's degree in life sciences, engineering, or a related scientific discipline
- 6–8 years of progressive experience in Regulatory Affairs within the medical device industry
- Strong knowledge of regulatory requirements and product lifecycle management for medical devices
- Proven experience preparing, submitting, and maintaining regulatory filings and approvals
- Ability to interpret regulations and translate regulatory requirements into practical business guidance
- Experience working in cross-functional, matrixed environments
- Fluency in Spanish and English (written and verbal)
- Moderate, primarily domestic with occasional international travel
Desired Qualifications
- Advanced degree
- Experience supporting product launches and significant product changes in regulated markets
- Prior people leadership or project leadership experience
- Experience working with global Regulatory Affairs teams and aligning local activities with global strategies
- Demonstrated ability to manage multiple priorities in a fast-paced environment
- Familiarity with U.S. and/or European medical device regulatory frameworks
- Regulatory Affairs certification
- Business Writing
- Compliance Risk
- Developing Others
- Fact-Based Decision Making
- Inclusive Leadership
- Industry Analysis
- Innovation
- Leadership
- Legal Support
- Operations Management
- Policy Development
- Product Licensing
- Public Policies
- Regulatory Affairs Management
- Regulatory Compliance
- Regulatory Development
- Regulatory Environment
- Strategic Thinking
- Team Management
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