Manager, Regulatory Affairs Brazil - DEPUY SYNTHES

Key Responsibilities

• Lead and manage regulatory submission, approval, and lifecycle activities for medical devices in Brazil.
• Develop and execute regulatory strategies that support new product introductions, product changes, and ongoing compliance.
• Prepare, submit, and maintain regulatory dossiers, registrations, renewals, and notifications in accordance with local requirements.
• Act as the primary regulatory liaison with Brazilian health authorities, maintaining effective and professional working relationships.
• Interpret regulatory requirements and clearly communicate risks, timelines, and impacts to internal stakeholders.
• Partner with Quality, Supply Chain, R&D, and Commercial teams to ensure regulatory compliance throughout the product lifecycle.
• Support regulatory inspections, audits, and inquiries, ensuring accurate responses and timely resolution of commitments.
• Contribute to continuous improvement of regulatory processes and promote a strong culture of compliance.
• Provide guidance, coaching, and day‑to‑day direction to regulatory team members or project contributors, as applicable.

Qualifications

Education

• Bachelor’s degree required in life sciences, engineering, or a related scientific discipline.
• Advanced degree preferred.

Experience and Skills

Required:

• 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.

Preferred:

• 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.
• Strong written and verbal communication skills with the ability to engage internal and external stakeholders.

Other:

• Languages: Fluency in Spanish and English (written and verbal) required.
• Travel: Moderate, primarily domestic with occasional international travel.
• Certifications: Regulatory Affairs certification preferred.

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Required Skills:

Preferred Skills:

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