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**Job Function: **
Regulatory Affairs Group
**Job Sub Function: **
Regulatory Affairs
Job Category:
People Leader
All Job Posting Locations:
Bogotá, Distrito Capital, Colombia, Mexico City, Mexico, 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) Director, QARA LATAM, Local Market Support, located in São Paulo, São Paulo or Bogota Colombia or Mexico City Mexico
Job Overview
The Director, QARA LATAM, Distribution & Ops provides strategic leadership for quality assurance and regulatory affairs across Latin America 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 diverse and highly regulated LATAM markets.
This role plays a critical role in safeguarding patient safety, enabling compliant business growth, and supporting long‑term portfolio 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 with country‑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, ensuring timely, 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, or a related discipline.
Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
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 business objectives.
Experience operating effectively 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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**Required Skills: **
Preferred Skills:
Business Writing, Collaborating, Compliance Risk, Continuous Improvement, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Operations Management, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking