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**Job Function: **
Quality
**Job Sub Function: **
Quality & Compliance Audit
Job Category:
Professional
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.
Job Overview
The Manager, Regulatory Compliance (LATAM) is responsible for leading and coordinating regulatory compliance activities through Internal audit 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 per DS Internal audit schedule.
Provide Compliance Expertise in the scope of gaps found during LATAM LOC/DC inspection readiness program lead by Quality partners
Identify and communicate Proactive compliance risk (Find it Fix it) to regional leaders for proactive assessments purposes.
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
Proactive identification and communication of risk to the region
Manage Regional LOC licences
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, or a related discipline (required).
Advanced degree in a scientific, regulatory, or business field (preferred).
_Experience and Skills: _
Required:
Typically 6-8 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 across LATAM markets.
Experience in leading compliance assessments.
Ability to manage complex compliance topics across multiple countries and stakeholder groups.
Preferred:
Auditing Experience in medical devices or healthcare,
Familiarity with LATAM regulatory authorities and compliance frameworks.
Experience working in a global or matrixed organization.
Exposure to regulatory inspections involving multi‑country operations.
Quality or Regulatory certifications (e.g., RAC, ASQ).
Strong analytical, risk‑management, and problem‑solving skills.
Effective written and verbal communication skills.
Other:
Language: English required; additional Portuguese and Spanish languages preferred.
Travel: Moderate regional travel across LATAM. Limited international travel
Certifications: Quality or Regulatory certifications preferred but not required.
For more information on how we support the whole health of our employees throughout their wellness, career and 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