Johnson & Johnson announced plans to separate our Orthopedics business toestablisha standalone orthopedics company,operatingas DePuy Synthes. The process of the planned separation isanticipatedto be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may berequired, regulatory approvals and other customary conditions and approvals. Should you accept this position, it isanticipatedthat, following conclusion of the transaction, you would be an employee of DePuy Synthesand your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes atan appropriate timeand subject to any necessary consultation processes.

TheDirector, QARA LATAM, Distribution & Opsprovides strategic leadership for quality assurance and regulatory affairs across Latin America as part of theInternational QARAorganization. This role is accountable for ensuring regulatory compliance, effective quality management system execution, and sustainable market access across diverse and highly regulated LATAM markets.

This roleplays a critical role in safeguarding patient safety, enabling compliant business growth, and supportinglong‑termportfolio success. The Director partners closely with Commercial, Operations, Supply Chain, Legal, and Global QARA leaders to manage quality and regulatory risk and guide regional strategy.

Key Responsibilities

• Lead and execute the Quality Assurance and Regulatory Affairs strategy across LATAM in alignment with global QARA objectives and international business priorities.

• Ensure ongoing compliance withcountry‑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, ensuringtimely, 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.

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

• Define distributor markets and design processes and systems that enable an efficient Distribution Management structure.

Qualifications

Education

• Required: Bachelor’s 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:

• 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 businessobjectives

• Experienceoperatingeffectively in global, matrixed organizations with senior executive stakeholder engagement.

• Strong leadership presence, sound judgment, and decision‑making capabilities in complex regulatory environments.

Preferred:

• Experience supporting or emerging market QARA operating models.

• Experience working in multinational or matrixed organizations.

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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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