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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
People Leader
All Job Posting Locations:
São Paulo, Brazil
Job Description:
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and 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 at an appropriate time and subject to any necessary consultation processes.
DePuy Synthes is recruiting for a(n) Associate Director, Quality Assurance & Regulatory Affairs (QARA) – Brazil / Southern Cluster, located in 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 the International QARA organization. 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, and long‑term market sustainability, including alignment with U.S. FDA and EU MDR pathways as applicable.
Ensure compliance with country‑specific 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 the International QARA organization.
Partner with cross‑functional 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.
Support and, as required, lead regulatory inspections, quality audits, and health authority interactions, ensuring timely and 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: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or a related discipline.
Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
Experience and Skills
Required:
8–10 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 multi‑country QARA portfolios or complex market clusters.
Proven ability to develop and execute integrated quality and regulatory strategies aligned with business objectives.
Strong leadership, stakeholder management, and decision‑making capabilities.
Ability to operate effectively in a global, matrixed organization.
Preferred:
Experience supporting International regulatory and quality operating models.
Experience working in multinational medical device or 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 required; Spanish preferred.
Travel: Moderate regional travel across Brazil and Southern Cluster markets.
Certifications: RAC or equivalent preferred but not required
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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**Required Skills: **
Preferred Skills:
Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Managing Managers, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking