Director, QARA LATAM – Distribution & Ops

Johnson & Johnson

Director of QARA for LATAM leading quality assurance and regulatory strategy. Ensuring compliance and fostering collaboration across commercial and operations teams.

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 ongoing compliance with country‑specific regulatory requirements, applicable regional standards, internal policies, and DePuy Synthes quality management system expectations
Provide strategic quality and regulatory guidance to support product registrations, renewals, variations, 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
Partner with cross‑functional stakeholders including Commercial, Operations, Supply Chain, Legal, and Global QARA to support product launches, supply continuity, and portfolio optimization
Monitor, interpret, and communicate regulatory, quality, and enforcement trends across LATAM, proactively assessing business and patient safety impact
Oversee and support regulatory inspections, quality audits, and health authority interactions, ensuring timely , consistent, and effective responses
Drive continuous improvement, harmonization, and simplification of QARA processes across LATAM markets
Lead, coach, and develop regional QARA leaders and teams, building strong capability, succession, and a culture of quality, compliance, and accountability
Define distributor markets and design processes and systems that enable an efficient Distribution Management structure

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
Employee respect and dignity
Diversity and merit recognition

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management SystemsRegulatory Strategy DevelopmentProduct Registration ManagementQuality AuditsRegulatory InspectionsCompliance Risk AssessmentLifecycle ManagementProcess ImprovementData AnalysisEnforcement Practices

Soft Skills

LeadershipCoachingCommunicationStakeholder EngagementTeam Development