Director, QARA – LATAM, Distribution & Ops

Johnson & Johnson

Director of Quality Assurance and Regulatory Affairs managing regulatory compliance across LATAM for DePuy Synthes. Leading QARA strategies and ensuring patient safety in highly regulated markets.

Posted 7/10/2026full-timeSão Paulo • 🇧🇷 BrazilLeadWebsite

About the role

Key responsibilities & impact

Provide strategic leadership for quality assurance and regulatory affairs across Latin America.
Ensure regulatory compliance and effective quality management system execution.
Provide strategic quality and regulatory guidance to support product registrations and full lifecycle management across LATAM markets.
Serve as the senior QARA escalation point for LATAM Local Market Support addressing regulatory, quality, and compliance risks.
Collaborate with cross‑functional stakeholders to support product launches and supply continuity.
Monitor and communicate regulatory, quality, and enforcement trends across LATAM.
Oversee regulatory inspections, quality audits, and health authority interactions.

Requirements

What you’ll need

Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
10–12 years of progressive experience in Quality Assurance and/or Regulatory Affairs within medical devices or other highly regulated industries.
Strong working knowledge of LATAM regulatory requirements, quality system standards, and enforcement practices.
Demonstrated experience leading multi‑country or regional QARA portfolios.
Proven ability to develop and execute integrated quality and regulatory strategies aligned with business objectives.
Experience operating effectively in global, matrixed organizations with senior executive stakeholder engagement.

Benefits

Comp & perks

Inclusive work environment
Competitive compensation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management System ExecutionRegulatory ComplianceProduct RegistrationQuality AuditsRegulatory InspectionsHealth Authority InteractionsIntegrated Quality StrategiesRegulatory Requirements KnowledgeMulti-Country QARA ManagementEnforcement Practices

Soft Skills

Strategic LeadershipStakeholder EngagementCollaborationCommunication