Manager, Reg Compliance (LATAM)

Job Overview

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 () and MDSAP

• Manage QMS Notification of change with NB.

• Work in closed collaboration with the Depuy Synthes regional Regulatory Compliance team

Qualifications

Education:

• Bachelors 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 involvingmulticountryoperations.

• Quality or Regulatory certifications (e.g. RAC ASQ).

• Strong analyticalriskmanagement andproblemsolvingskills.

• Effective written and verbal communication skills.

Other:

• Language: English;additionalPortuguese and Spanishlanguages preferred.

• Travel: Moderate regional travel acrossLATAM.Limited international travel

• Certifications: Quality or Regulatory certifications preferred but not.

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