Associate Dir, QARA BR S. Cluster

DePuy Synthes is recruiting for a(n) Associate Director Quality Assurance & Regulatory Affairs (QARA) Brazil / Southern Clusterlocatedin São Paulo São Paulo Brazil.

Job Overview

The Associate Director Quality Assurance & Regulatory Affairs (QARA) Brazil / Southern Cluster provides strategic and operational leadership for quality assurance and regulatory affairs across Brazil and the Southern Cluster as part of theInternational QARAorganization.This role is accountable for ensuring regulatory compliance effective quality management system execution and sustainable market access across highly regulated Latin American markets.

This position plays a key leadership role within the international QARA organization. The Associate Director partners closely with Commercial Operations Supply Chain Quality and Global QARA teams to manage quality and regulatory risk shape regional QARA strategy and enable compliant business growth while safeguarding patient safety.

Key Responsibilities

• Lead and oversee Quality Assurance and Regulatory Affairs strategy and execution across Brazil and the Southern Cluster in alignment with global QARA objectives and international priorities.

• Develop and execute integrated quality and regulatory strategies to support product registrations notifications approvals andlongtermmarketsustainability including alignment with U.S. FDA and EU MDR pathways as applicable.

• Ensure compliance with countryspecific regulatory requirements quality management system standards and internal policies and procedures.

• Provide strategic quality and regulatory guidance to support product registrations renewals variations and full lifecycle management across the cluster.

• Serve as the senior QARA escalation point for Brazil / Southern Cluster Local Market Support within theInternational QARAorganization.

• Partner with crossfunctional stakeholders including Commercial Quality Supply Chain Legal and Global QARA to support product launches supply continuity and portfolio optimization.

• Monitor regulatory quality and enforcement trends across Brazil and Southern Cluster markets proactively assessing business and compliance impact.

• Supportandas lead regulatory inspections quality audits and health authority interactions ensuringtimelyand effective responses.

• Drive continuous improvement simplification and harmonization of QARA processes across Brazil and Southern Cluster markets.

• Lead coach and develop QARA talent fostering a strong culture of quality compliance accountability and performance.

• Ensuring proactive engagement and shaping of regional policy initiatives that are critical to business strategy continuity and growth.

Qualifications

Education

• Required: Bachelors degree in Regulatory Affairs Life Sciences Engineering ora relateddiscipline.

• Preferred: Advanced degree or professional certification in Regulatory Affairs Quality ora relatedfield.

Experience and Skills

Required:

• 810 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device healthcare or other highly regulated industries.

• Strong working knowledge of Brazilian and Southern Cluster regulatory requirements health authority processes and quality system expectations.

• Demonstrated experience leading multicountry QARA portfolios or complex market clusters.

• Proven ability to develop and execute integrated quality and regulatory strategies aligned with businessobjectives.

• Strong leadership stakeholder management and decisionmaking capabilities.

• Ability tooperateeffectively in a global matrixed organization.

Preferred:

• Experience supportingInternationalregulatory and quality operating models.

• Experience working in multinational medicaldeviceor healthcare organizations.

• Exposure to regulatory inspections quality audits and authority negotiations in Latin America.

• Demonstrated success driving QARA transformation process improvement or operational simplification initiatives.

• Regulatory Affairs or Quality certification (e.g. RAC or equivalent).

Other

• Language: Portuguese and English; Spanish preferred.

• Travel: Moderate regional travel across Brazil and Southern Cluster markets.

• Certifications: RAC or equivalent preferred but not

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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