At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com
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Job Function:
Quality
Job Sub Function:
Quality & Compliance Audit
Job Category:
Professional
All Job Posting Locations:
São Paulo, Brazil
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.
The Manager, Regulatory Compliance (LATAM)isresponsible forleading and coordinating regulatory compliance activities throughInternalaudit program across Local Operating Companies (LOCs) and Distribution Centers (DCs) in the LATAM region. This role ensures consistent adherence to applicable regulatory requirements, quality system standards, and internal policies across multiple countries. The position has a meaningful impact on patient safety, regulatory readiness, and sustainable business operations by proactively managing compliance risk and partnering closely with Quality, Regulatory Affairs, Commercial, and Supply Chain teams.
Key Responsibilities
Lead schedule development of internal audits in the region, support response development.
Conduct and review internal audits as perDSInternal audit schedule.
Provide Compliance Expertise in the scope of gaps found during LATAM LOC/DC inspection readiness program lead by Quality partners
Identifyand communicate Proactive compliance risk (Find it Fix it) to regional leaders for proactiveassessmentspurposes.
Partner with Regulatory Affairs, Quality, Commercial, and Supply Chain teams to support compliant product distribution and lifecycle activities.
Escalate early signal and compliance issue, risk to management through data analytics and reporting
Proactiveidentificationand communication of risk to the region
Manage Regional LOClicences
Develop & Manage regional LM / DC /LOC Certification process for ISO (13485, 9001) and MDSAP
Manage QMS Notification of change with NB.
Work in closed collaboration with the Depuy Synthes regional Regulatory Compliance team
Qualifications
Education:
Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, ora relateddiscipline (required).
Advanced degree in a scientific, regulatory, or business field (preferred).
Experience and Skills:
Required:
Typically6-8 years of progressive experience in Regulatory Compliance, Quality, or related roles within a regulated industry.
Strong experience & skills as lead auditor for internal auditing
Strong knowledge of regulatory and compliance requirements applicable acrossLATAMmarkets.
Experienceinleading compliance assessments.
Ability to manage complex compliance topics across multiple countries and stakeholder groups.
Preferred:
Auditing Experience in medical devices orhealthcare ,
Familiarity withLATAMregulatory authorities and compliance frameworks.
Experience working in a global or matrixed organization.
Exposure to regulatory inspections involvingmulti‑countryoperations.
Quality or Regulatory certifications (e.g., RAC, ASQ).
Strong analytical,risk‑management, andproblem‑solvingskills.
Effective written and verbal communication skills.
Other:
Language: Englishrequired;additionalPortuguese and Spanishlanguages preferred.
Travel: Moderate regional travel acrossLATAMLimited international travel
Certifications: Quality or Regulatory certifications preferred but notrequired
For more information on how we support the whole health of our employees throughout their wellness,careerand life journey, please visit www.careers.jnj.com
Required Skills:
Preferred Skills:
Agile Internal Audit, Analytical Reasoning, Audit and Compliance Trends, Compliance Frameworks, Compliance Management, Compliance Policies, Compliance Risk, Critical Thinking, Process Improvements, Quality Auditing, Quality Control (QC), Quality Standards, Regulatory Compliance, Risk Management, Technical Credibility, Third-Party Auditing
At Johnson & Johnson, we believe health is everything. As a focused healthcare company, with expertise in Innovative Medicine and MedTech, we’re empowered to tackle the world’s toughest health challenges, innovate through science and technology, and transform patient care.
All of this is possible because of our people. We’re passionate innovators who put people first, and through our purpose-driven culture and talented workforce, we are stronger than ever.
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